| Last revision date: 06/04/2020 | Revisión: 4 |
Introduction
This instructions show indications, contraindications, warnings and methods of use of the Delta Abutments system.
Warnings
Following warnings apply globally to the whole Delta Abutments System.
In case of doubt please contact the manufacturer.
The product is designed to be single-used. Do not reuse product.
Mechanical properties of a reused product may have been altered and the implant connection damaged.
Sinumetrics Systems can not guarantee the correct performance of a reused product.
Delta Abutments Systems clinical abutments must only be used by odontology professionals specialized in implantology and prosthetics.
If Delta Abutment systems is used by non specialised personnel , possible defects as well as new material reclaim will not be covered by guarantee.
Sinumetrics Systems recommends procedural use of dental product by the customer to guarantee the processes used are performed as intended. These processes include: Inspection of purchased material, surgical planification, cleansing, sterilisation, clinical case review, surgical procedure, systematic review plan and customer complaints among other.
For the correct use of Delta Abutment System it is recommended to use indicated instrumentation.
Intended use
Delta Abutment System’s intended use is to successfully complete dental prostheses restoration processes in the clinical or laboratory environment.
Contraindications
Delta Abutment systems is not intended to be used on patients suffering from allergies or other harmful reactions to materials of the system. Please read carefully table 1 to identify the component meant to be used and the material it’s made of. According to customer protocols, Sinumetrics Systems recommends compiling all the important information about the patient to avoid this potential negative effects.
Some patient’s habits such as dental hygiene and smoking can affect negatively to abutment’s system’s intended use. It is recommended to inform the patient about the importance of healthy dental habits.
Compatibility with other products
Delta Abutment system is designed and tested so it’s intended use is meant to be used with other products from other brands. Please check table 2 regarding compatibilities and make sure the product that has been planned to be used is suitable for the dental implants the patient is using.
Information regarding cleaning and sterilisation
Cleaning
Cleaning is performed by Sinumetrics Systems. In case the customer needs to perform cleaning according his or her procedures, it is recommended to use neutral detergent, whether is manual or automated cleaning.
Sterilisation
Sinumetrics Systems does not perform Sterilisation to Delta Abutment system. Sinumetrics recommends the following indications to sterilise the medical device (in accordance with standard EN ISO 17665-1:2006):
- To correctly sterilise the medical device, original packaging must be disposed and put on a double bag of sterilisation paper roll thermosealed at 175ºC. (This settings have been validated with AMCOR BOP MIXED ROLLS in paper 60gr/m2 and film PE-PP (12/40 μm) 53gr/m2) and a thermosealing machine Matachana 680 DE-V).
- To correctly sterilise medical devices, pre-vacuum autoclaving has to be performed at 121ºC during 30 minutes with a drying time of 15 minutes. (This settings have been validated in a Matachana M30-B autoclave machine)
This processes are validated by outsourced analysis laboratories. Other equivalent sterilization methods can be used as long as they are to be validated by the user according to EN ISO 17665-1:2006 and EN ISO 11607-1:2017.
Products
01-Scanbody-Intended use and indications for use
Intended use of scanbodies is laboratory work model scans to determine dental implant position.
Scanbodies are linked to digital files associated to it’s scanning system. Scanbodies are not intended to be used with the patient. They can only be used with laboratory dental model. Scanbodies must be connected to the analogs of the work model and scan them.It is necessary to check scanbodies correct fitting for accurate scanning. It is highly recommended to check scanbodies wear out. If, due to wear, connection does not fit accordingly, scanning information may be wrong.
02-Analog-Intended use and indications for use
Intended use of analogs is laboratory model creation with the exact position of the analogs where implants should be in mouth. Analog can be reused, however the customer must check no damage has altered the connection. I this is so this can lead to wrong measurements and incorrect prostheses adjustments.
03-Laboratory Screw-Intended use and indications for use
Intended use of the lab screw is the manipulation of the dental prosthesis with ease in the laboratory dental model. The use of this screw is specifically intended to work with restorations which use acrylic resin in prosthesis manufacturing.
04-05-Castable-Intended use and indications for use
Intended use of castable is the manufacturing of prostheses using casting through lost wax technique.
Castable replicates connection and has retentions for wax to adhere properly. Casting is a manual process in which several variables intervene. Responsability for castable use is on the customer.
06-Open tray transfer-Intended use and indications for use
Intended use of open tray transfer is correct transference of the position of the implants from patient’s mouth to a work model.Open tray transfer is indicated to be used in the open tray measuring procedure.
07-Closed tray transfer-Intended use and indications for use
Intended use of closed tray transfer is the correct transference of he position of the implants from patient’s mouth to a work model. Closed tray transfer is indicated to be used in the closed tray measuring procedure.
08-Implant cap-Intended use and indications for use
Intended use of implant cap is to isolate the connection of the implant from possible damage or contamination during surgical procedure. It is indicated for rehabilitations that use immediate load or measuring techniques and other procedures that may be performed during implant positioning surgery.
09-29-Clinical screw-Intended use and indications for use
The intended use of clinical screw is fixing abutment and prosthesis to the implant. It is recommended to screw the product at the recommended maximum torque indicated in table.3. It is recommended to apply recommended torque and 10 minutes later apply that torque again.
10-Millable abutment-Intended use and indications for use
The intended use of the millable abutment is to create an artificial custom hand-made stump.
It is indicated to perform this procedure as far as possible from the patient. The scrap metal may be harmful to the patient.
11-Temporary abutment-Intended use and indications for use
The intended use of the temporal abutment is to support provisional restorations made in acrylic resin.
To manufacture this restorations the abutment can be milled to desired shape. It is indicated to perform this procedure as far as possible from the patient. The scrap metal may be harmful to the patient.
12-Healing Abutment-Intended use and indications for use
The intended use of the healing abutment is to protect the connection of the implant during implant stability phases of primary and secondary stability. Additionally it’s rounded shape is meant for the gingiva to recover safely. The recommended maximum torque is indicated in table.3. It is recommended to apply recommended torque and 10 minutes later apply that torque again.
13-14-15-Multiunit abutment-Intended use and indications for use
Intended use of the Multiunit abutment is to be used as a base for fixed screw restorations.
The recommended maximum torque is indicated in table.3. It is recommended to apply recommended torque and 10 minutes later apply that torque again.
Product labeling indicates screw metrics, it’s maximum torque recommended for its screw is idicated in table.3.
Additionally, the abutment final restorations has to be screwed with screw REF:090931 which has an M1.4 class thread. The recommended maximum torque for this screw is indicated in table.3.
16-17-18-19-26-38-Interface-Intended use and indications for use
Intended use of the interface is to create an intermediate connection for cemented based restorations. The client must plan the use for these interfaces taking into account which implants are in patient’s mouth and which type of restoration must be crafted, whether it is single or multiple.
20-Locator-Intended use and indications for use
Intended use for locator is anchoring of implant supported bars with removable provisional prosthetics.
Locator has an M2.0 class thread. The recommended maximum torque for this screw is indicated in table.3.
31-Scanbody-Intended use and indications for use
Intended use of scanbodies is to scan patient’s mouth in order to determine dental implant position.
Scanbodies are linked to digital files associated to it’s scanning system. Scanbodies must be connected to the analogs of the work model and scan them.It is necessary to check scanbodies correct fitting for accurate scanning. It is highly recommended to check scanbodies wear out. If, due to position, connection does not fit accordingly, scanning information may be wrong.
Label indications
 | Product brandReference of the productLOT numberManufacturing dateWarningsOnline site for instructions for use CE marking and Notified body code (0123, TÜV-SÜD)Symbol indications (non reusable, non sterile. etc.)Manufacturer and it’s address. (Sinumetrics Systems S.A.L. C/Tecnica 75, 08740, Sant Andreu de la Barca, Barcelona, Spain.)Date of the last revision of the label |
Information Tables
| Table.1 Information about components of Delta Abutment System | |||
| Product | Códe(*) | Class according MDD CE 93/42 | Material |
| Scanbody | 01RRRR | N/A | Aluminum |
| Analog | 02RRRR | N/A | Stainless steel 304 L |
| Laboratory Screw | 03RRRR | N/A | Stainless steel 304 L |
| Rotary Castable | 04RRRR | N/A | POM |
| Anti-Rotary Castable | 05RRRR | N/A | POM |
| Open tray transfer | 06RRRR | IIa | Titanium g.V |
| Closed tray transfer | 07RRRR | IIa | Titanium g.V |
| Implant cap | 08RRRR | IIa | Titanium g.V |
| Clinical screw | 09RRRR29RRRR | IIb | Titanium g.V |
| Millable abutment | 10RRRR | IIb | Titanium g.V |
| Temporary abutment | 11RRRR22RRRR | IIb | Titanium g.V |
| Healing Abutment | 12RRRR | IIb | Titanium g.V |
| Multiunit abutment | 13RRRR14RRRR15RRRR | IIb | Titanium g.V |
| Rotary Interface 0,5mm | 16RRRR17RRRR18RRRR19RRRR26RRRR38RRRR | IIb | Titanium g.V |
| Locator | 20RRRR | IIa | Titanium g.V |
| Scanbody Intraoral | 31RRRR | IIa | Titanium g.V |
| Code expressed with letter R refers to the compatible connection shown in table.2 |
| Table.2 Compatibility references naming | |
| 0111 | compatible with 3i Certain 3.4 |
| 0112 | compatible with 3i Certain 4.1 |
| 0113 | compatible with 3i Certain 5.0 |
| 0121 | compatible with 3i Externa 3.4 |
| 0122 | compatible with 3i Externa 4.1 |
| 0123 | compatible with 3i Externa 5.0 |
| 0211 | compatible with Adin Interna 3.5 |
| 0311 | compatible with Astra Tech Yellow |
| 0312 | compatible with Astra Tech Aqua |
| 0313 | compatible with Astra Tech Lilac |
| 0321 | compatible with Astra Evo 3.6 |
| 0322 | compatible with Astra Evo 4.2 |
| 0323 | compatible with Astra Evo 4.8 |
| 0324 | compatible with Astra Evo 3.0 |
| 0331 | compatible with Astra Evo Multiunit |
| 0341 | compatible with Astra Pilar 20º |
| 0342 | compatible with Astra Pilar 45º |
| 0411 | compatible with Avinent Externa 3.5 |
| 0412 | compatible with Avinent Externa 4.0 |
| 0421 | compatible with Avinent Interna 3.5 |
| 0422 | compatible with Avinent Interna 4.0 |
| 0511 | compatible with Bego Interna 3.75 |
| 0512 | compatible with Bego Interna 4.5 |
| 0611 | compatible with BioHorizons Interna 3.0 |
| 0612 | compatible with BioHorizons Interna 3.5 |
| 0613 | compatible with BioHorizons Interna 4.5 |
| 0614 | compatible with BioHorizons Interna 5.7 |
| 0621 | compatible with BioHorizons Externa 3.5 |
| 0622 | compatible with BioHorizons Externa 4.0 |
| 0623 | compatible with BioHorizons Externa 5.0 |
| 0624 | compatible with BioHorizons Externa 6.0 |
| 0711 | compatible with BTI Externa 3.5 |
| 0712 | compatible with BTI Externa 4.1 |
| 0713 | compatible with BTI Externa 5.5 |
| 0721 | compatible with BTI Interna 3.5 |
| 0722 | compatible with BTI Interna 4.0 |
| 0723 | compatible with BTI Interna 5.5 |
| 0731 | compatible with BTI Unit 4.0 |
| 0732 | compatible with BTI Unit 5.5 |
| 0811 | compatible with Mis Interna NARROW |
| 0812 | compatible with Mis Interna 3.75 |
| 0813 | compatible with Mis Interna 4.5 |
| 0814 | compatible with Mis Interna 5.7 |
| 0821 | compatible with Mis Multiunit |
| 0822 | compatible with Mis Multiunit Angulado |
| 0911 | compatible with Nobel Active NP |
| 0912 | compatible with Nobel Active RP |
| 0921 | compatible with Nobel Branemark NP |
| 0922 | compatible with Nobel Branemark RP |
| 0923 | compatible with Nobel Branemark WP |
| 0931 | compatible with Nobel Multiunit RP |
| 0932 | compatible with Nobel Multiunit WP |
| 0941 | compatible with Nobel Replace NP |
| 0942 | compatible with Nobel Replace RP |
| 0943 | compatible with Nobel Replace WP |
| 0944 | compatible with Nobel Replace 6.0 |
| 1011 | compatible with Straumann Bone Level NC |
| 1012 | compatible with Straumann Bone Level RC |
| 1021 | compatible with Straumann Tissue Level RN |
| 1022 | compatible with Straumann Tissue Level WN |
| 1031 | compatible with Straumann Pilar Tissue Level RN |
| 1032 | compatible with Straumann Pilar Tissue Level WN |
| 1041 | compatible with Straumann Pilar Bone level |
| 1111 | compatible with Sweden Martina Externa 3.3 |
| 1112 | compatible with Sweden Martina Externa 4.1 |
| 1113 | compatible with Sweden Martina Externa 5.0 |
| 1121 | compatible with Sweden Martina Kohno 3.3 |
| 1122 | compatible with Sweden Martina Kohno 3.8 |
| 1123 | compatible with Sweden Martina Kohno 4.25 |
| 1124 | compatible with Sweden Martina Kohno 5.0 |
| 1211 | compatible with Zimmer TSV Green |
| 1212 | compatible with Zimmer TSV Purple |
| 1213 | compatible with Zimmer TSV Yellow |
| 1311 | compatible with Dentsply Xive 3.4 |
| 1312 | compatible with Dentsply Xive 3.8 |
| 1313 | compatible with Dentsply Xive 4.5 |
| 1321 | compatible with Dentsply Xive TG 4.8 |
| 1511 | compatible with Camlog Interna 3.8 |
| 1612 | compatible with Eckermann Interna 4.3 |
| 1711 | compatible with Galimplant Interna |
| 1721 | compatible with Galimplant Pilar Recto Rotatorio |
| 1722 | compatible with Galimplant Pilar Recto Antirrotatorio |
| 1731 | compatible with Galimplant Externa 4.0 |
| 1732 | compatible with Galimplant Externa 5.0 |
| 1811 | compatible with Implant Direct Legacy 3.0 |
| 1911 | compatible with Klockner Essential 4.5 |
| 1912 | compatible with Klockner Essential 6.0 |
| 1921 | compatible with Klockner Octa 4.5 |
| 1922 | compatible with Klockner Octa 6.0 |
| 1931 | compatible with Klockner SK2 3.3 |
| 1932 | compatible with Klockner SK2 4.2 |
| 1933 | compatible with Klockner SK2 5.5 |
| 1941 | compatible with Klockner Vega MV |
| 1942 | compatible with Klockner Vega NV |
| 1943 | compatible with Klockner Vega RV |
| 1951 | compatible with Klockner SH |
| 2011 | compatible with Megagen Anyridge 3.3 |
| 2012 | compatible with Megagen Anyridge 3.75 |
| 2021 | compatible with Megagen Octa 3.8 |
| 2022 | compatible with Megagen Octa 4.8 |
| 2111 | compatible with Neodent CM Interna |
| 2121 | compatible with Neodent GM Interna 4.8 |
| 2131 | compatible with Neodent CM Pilar 3.5 |
| 2132 | compatible with Neodent CM Pilar AR |
| 2133 | compatible with Neodent CM Pilar RO |
| 2141 | compatible with Neodent GM Pilar Micro |
| 2142 | compatible with Neodent GM Pilar Mini |
| 2151 | compatible with Neodent Externa 3.3 |
| 2152 | compatible with Neodent Externa 4.3 |
| 2153 | compatible with Neodent Externa 5.1 |
| 2211 | compatible with OXY Multiunit 5.0 |
| 2311 | compatible with Phibo Aurea Evo 3.5 |
| 2312 | compatible with Phibo Aurea Evo 4.3 |
| 2313 | compatible with Phibo Aurea Evo 5.4 |
| 2321 | compatible with Phibo TSA S3 |
| 2322 | compatible with Phibo TSA S4 |
| 2323 | compatible with Phibo TSA S5 |
| 2331 | compatible with Phibo TSH S2 |
| 2332 | compatible with Phibo TSH S3/S4 |
| 2333 | compatible with Phibo TSH S5 |
| 2341 | compatible with Phibo ConHex 4.75 |
| 2411 | compatible with Samo Interna 4.2 |
| 2511 | compatible with Anthogyr Axiom BL 2.8 |
| 2512 | compatible with Anthogyr Axiom BL |
| 2521 | compatible with Anthogyr Axiom TL |
| 2531 | compatible with Anthogyr Axiom MultiLevel |
| 2611 | compatible with Ziacom Interna 4.0 |
| 2612 | compatible with Ziacom Interna 5.0 |
| 2621 | compatible with Ziacom Externa 3.3 |
| 2622 | compatible with Ziacom Externa 4.0 |
| 2623 | compatible with Ziacom Externa 5.0 |
| 2631 | compatible with Ziacom Zinic NP |
| 2632 | compatible with Ziacom Zinic RP |
| 2633 | compatible with Ziacom Zinic WP |
| 2711 | compatible with JD Evolution S |
| 2712 | compatible with JD Evolution |
| 2713 | compatible with JD Evolution Plus+ |
| 2721 | compatible with JD Icon UltraS |
| 2811 | compatible with Microdent Genius 3.0 |
| 2812 | compatible with Microdent Genius 3.5 |
| 2813 | compatible with Microdent Genius 4.0 |
| 2814 | compatible with Microdent Genius 4.5 |
| 2815 | compatible with Microdent Genius 5.0 |
| 2821 | compatible with Microdent System 3.5 |
| 2822 | compatible with Microdent System 4.2 |
| 2823 | compatible with Microdent System 5.1 |
| 2824 | compatible with Microdent System 5.6 |
| 2831 | compatible with Microdent Universal 3.5 |
| 2832 | compatible with Microdent Universal 4.1 |
| 2833 | compatible with Microdent Universal 5.1 |
| 2834 | compatible with Microdent Universal 5.6 |
| 2841 | compatible with Microdent Trylogic 3.8 |
| 2842 | compatible with Microdent Trylogic 4.3 |
| 2843 | compatible with Microdent Trylogic 5.1 |
| 2844 | compatible with Microdent Trylogic 5.5 |
| 2851 | compatible with Microdent EK 3.5 |
| 2852 | compatible with Microdent EK 4.5 |
| 2853 | compatible with Microdent EK 5.7 |
| 2911 | compatible with GMI Frontier RP |
| 2912 | compatible with GMI Frontier WP |
| 2921 | compatible with GMI Phoenix Estrecha |
| 2922 | compatible with GMI Phoenix Estándar |
| 2923 | compatible with GMI Phoenix Ancha |
| 2924 | compatible with GMI Phoenix Extra-Ancha |
| 2931 | compatible with GMI Avantgard RP |
| 2932 | compatible with GMI Avantgard WP |
| 2941 | compatible with GMI Monolith |
| 3011 | compatible with TBR Infinity 3.5 |
| 3012 | compatible with TBR Infinity 4.0 |
| 3013 | compatible with TBR Infinity 5.0 |
| 3021 | compatible with TBR Infinity Z1 3.5 |
| 3022 | compatible with TBR Infinity Z1 4.0 |
| 3023 | compatible with TBR Infinity Z1 5.0 |
| 3111 | compatible with Paltop Internal Hex Narrow |
| 3112 | compatible with Paltop Internal Hex Standard |
| 3113 | compatible with Paltop Internal Hex Wide |
| 3121 | compatible with Paltop Conical |
| 3211 | compatible with Radhex Interna IS |
| 3212 | compatible with Radhex Interna IM |
| 3221 | compatible with Radhex Externa ES |
| 3222 | compatible with Radhex Externa EM |
| 3311 | compatible with Intralock Gold&Blue Gs |
| 3312 | compatible with Intralock Gold&Blue Gw |
| 3321 | compatible with Intralock InDex Estrecho |
| 3322 | compatible with Intralock InDex Estándar |
| 3323 | compatible with Intralock InDex Ancha |
| 3331 | compatible with Intralock IntraHex 3.5 |
| 3332 | compatible with Intralock IntraHex 4.5 |
| 3341 | compatible with Intralock UniHex |
| 3351 | compatible with Intralock Flatone 3.5 |
| 3352 | compatible with Intralock Flatone 5..0 |
| 3411 | compatible with Alpha Bio IH 3.75/4.2/5.0 |
| 3421 | compatible with Alpha Bio CHC NIce |
| 3422 | compatible with Alpha Bio CHC Ice |
| 3511 | compatible with Mozo Grau Inhex Mini |
| 3512 | compatible with Mozo Grau Inhex STD |
| 3521 | compatible with Mozo Grau Osseus Mini |
| 3522 | compatible with Mozo Grau Osseus STD |
| 3621 | compatible with Dentium Supeprline/Implantum |
| Please check the reference you plan to use exists before ordering. Check online catalog or contact Sinumetrics Systems. Not all cross references exist for all components. |
| Table.3 Maximum torque according to M class thread. | |
| M class | Torque [N·cm] |
| M1.4 | 15 |
| M1.6 | 20 |
| M1.8 | 25 |
| M2.0 | 30 |
| M2.5 | 40 |