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510(k) Data Aggregation
(421 days)
Multi-Unit DAS System is intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
Compatible Implant Systems
| Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform Diameter, mm or Name |
|---|---|---|
| Astra Tech EV (Internal Taper) | 3.6 | 3.6 |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| Osstem® TS Hiossen® ET (Internal Taper) | 3.5 | Mini |
| 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | |
| Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM |
| Straumann Bone Level (CrossFit® Morse Taper) | 3.3 | NC |
| 4.1, 4.8 | RC | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB/WB |
All digitally designed custom abutments for use with Multi-Unit DAS System are to be sent to a Talladium validated milling center for manufacture.
Multi-Unit DAS System abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration
Multi-Unit DAS system abutments are designed for retention of multi-unit or single-unit restorations. The multi-unit abutments are provided in a straight design (no angulation in the base portion) that threads directly to the OEM implant. For all compatible OEM implant lines, the multi-unit abutment components are provided with gingival heights ranging from 1 mm to 4 mm, a prosthetic platform diameter of 4 mm, and a prosthetic post height of 1.4 mm.
This submission includes one (1) abutment level Ti-Base (coping) Engaging Interface for use with the subject multi-unit abutments. The subject Ti-Base (coping) Engaging Interface is a straight prepable design with an additional gingival height of 1.5 mm and a prepable 10.5 mm prosthetic post. This Ti-Base (coping) Engaging Interface has an engaging interface to the multi-unit abutments and is to be used to fabricate a straight final abutment and a straight final restoration. The subject device is identical to the previously cleared abutment level Ti-base (Part 35.312.209.21-2, K231559), except the current subject device has an engaging interface. The previously cleared abutment level Ti-base (Part 35.312.209.21-2, K231559) is to be used to fabricate a straight final abutment and a straight final restoration.
The subject device multi-unit abutments may be used with the following components, all previously cleared in K231559: Straight Ti-base, non-engaging, part number 35.312.209.21-2; DAS Multi-Unit Engaging Dynamic Ti-Base, part number 31.312.209.01-2; DAS Multi-Unit Non-Engaging Dynamic Ti-Base, part number 31.322.209.01-2; DAS Multi-Unit Non-Engaging Dynamic Ti-Base, part number 31.322.209.21-2; DAS Multi-Unit Healing Cap Regular, part number 40.320.003.88-2; DAS Multi-Unit Healing Cap Wide, part number 40.320.003.89-2; DAS Multi-Unit Dynamic Screw 3.0, part number 41.320.040.01-2; DAS Multi-Unit Provisional Dynamic Screw, part number 41.320.050.02-2; and DAS Multi-Unit Straight Screw, part number 40.320.003.06-2.
No new DAS Multi-Unit Dynamic Ti-Bases are included in this submission. The previously cleared DAS Multi-Unit Dynamic Ti-Base (coping) components (K231599), part numbers 31.312.209.01-2, 31.322.209.01-2, and 31.322.209.21-2 may be used with the subject device Angled Multi-Unit abutments to fabricate a final angled abutment.
A summary of the subject device Multi-Unit DAS System abutment compatibilities with the OEM implants is provided in the following Table 1 Summary of Compatibilities.
Table 1 Summary of Compatibilities
| Compatible Dental Implant Connections | Subject Device: Multi-Unit DAS System |
|---|---|
| Compatible Implant System (Connection) | Implant Body Diameter, mm |
| Astra Tech EV (Internal Taper) | 3.6 |
| 4.2 | |
| 4.8 | |
| Osstem® TS Hiossen® ET (Internal Taper) | 3.5 |
| 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | |
| Neodent (Morse taper GM) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 |
| Straumann Bone Level (CrossFit® Morse Taper) | 3.3 |
| 4.1, 4.8 | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 |
All zirconia superstructures for use with the subject device Multi-Unit DAS system will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.
The design parameters for the CAD-CAM zirconia superstructure for the subject Multi-Unit DAS Dynamic Ti-base are:
- Minimum wall thickness – 0.25 mm
- Minimum post height for single-unit restorations – 4.0 mm
(post height measured above the gingival height of the final patient-matched design) - Maximum gingival height – 4.90 mm
- Minimum gingival height – 3.89 mm
- Maximum angulation – 15°
The design parameters for the CAD-CAM zirconia superstructure for the subject device Multi-Unit DAS Ti-Base (coping) Engaging Interface are:
- Minimum wall thickness – 0.25 mm
- Minimum post height for single-unit restorations – 4.0 mm
(post height measured above the gingival height of the final patient-matched design) - Maximum gingival height – 4.90 mm
- Minimum gingival height – 3.89 mm
- Maximum angulation – 0°
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