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510(k) Data Aggregation
(128 days)
Dentis SQ -SL AXEL Fixture is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
Dentis SQ-SL AXEL Fixture is two types as Mini and Regular according to the connection. Dentis SQ-SL AXEL Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.
The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching).
The dimensions of fixtures are as following:
| No. | Device Name | Dimension Ranges |
|---|---|---|
| 1 | SQ-SL AXEL Fixture | Ø4.2, 4.6, 5.0, 5.4, 6.0, 7.0 (D) X 7.0, 7.5, 8.5, 9.5, 11.5, 13.5, 15.5, 17.5mm |
| 2 | SQ-SL AXEL Fixture Mini | Ø3.8, 4.2 (D) X 7.5, 8.5, 9.5, 11.5, 13.5, 15.5, 17.5mm |
Tolerance of dimension shall be within ± 1% range.
Dentis SQ-SL Fixture is compatible with K192688 and K210134 as below:
| 510(K) | Abutment Name | Diameter(∅) | Angulation | Length(mm) |
|---|---|---|---|---|
| K192688 | s-Clean Cover Screw | Ø3.6mm | 0 | 5.9mm |
| s-Clean (TiN Half Coating) Sole Abutment S-Line | Ø4.5, 5.5, 6.5 and 7.5 | 0 | 11.6, 12.6 and 13.6 | |
| K210134 | s-Clean (TiN Half Coating) Angled Abutment | Ø4.5 | 15 | 12.6 |
Dentis SQ-SL Fixture Mini is compatible with K210080 as below:
| 510(K) | Abutment Name | Diameter (∅) | Angulation | Length(mm) |
|---|---|---|---|---|
| K210080 | s-Clean Cover Screw Mini | Ø3.2mm | 0 | 5.0mm |
| s-Clean Healing Abutment S-Line Mini | Ø4.3, 4.8 and 5.8 | 0 | 7.61, 8.61, 9.61, 10.61, 11.61, 12.61 and 14.61 | |
| s-Clean (TiN Half Coating) Sole Abutment Mini | Ø4.5 and 5.5 | 0 | 11.01, 12.01, 12.51, 13.01, 13.521, 14.01, 14.51, 15.01, 15.51, 16.01 and 17.01 | |
| s-Clean (TiN Half Coating) Couple Abutment Mini | Ø4.0, 4.5 and 5.5 | 0 | 8.35, 8.6, 9.35, 9.6, 9.85, 10.1, 10.35, 10.6, 11.1, 11.35, 11.6, 12.1, 12.85, 13.1, 13.35, 13.6, 14.35 and 14.6 | |
| s-Clean (TiN Half Coating) Angled Abutment Mini | Ø4.0 and 4.5 | 15 | 12.09, 12.34, 12.51 and 12.76 |
Dentis SQ-SL AXEL Fixture is provided sterilized.
Dentis SQ-SL AXEL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.
Materials:
- SQ-SL AXEL Fixture and SQ-SL AXEL Fixture Mini are fabricated from Pure titanium of ASTM F67
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