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510(k) Data Aggregation
(88 days)
Dentis s-Clean SQ-SL Fixture
Dentis s-Clean SQ-SL 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 s-Clean SQ-SL Fixture is two type as Mini and Regular according to the connection. Dentis s-Clean SQ-SL 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 | s-Clean SQ-SL Fixture | Ø4.35, 4.8 and 5.2 (D) X 15.5 and 17.5mm |
| 2 | s-Clean SQ-SL Fixture Mini | Ø3.7 and 4.1 (D) X 15.5 and 17.5 |
Tolerance of dimension shall be within ± 1% range.
s-Clean SQ-SL Fixture is compatible with devices in K192688 and K210134 as below:
| 510(K) | Abutment Name | Diameter(Ø) | Angulation | Length(mm) |
|---|---|---|---|---|
| K192688 | s-Clean Cover Screw | Ø3.6mm | 0 | 5.9mm |
| K192688 | s-Clen (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-Celan (TiN Half Coating) | |||
| Angled Abutment | Ø4.5 | 15 | 12.6 |
s-Clean SO-SL Fixture Mini is compatible with devices in K210080 as below:
| 510(K) | Abutment Name | Diameter(Ø) | Angulation | Length(mm) |
|---|---|---|---|---|
| K210080 | s-Clean Cover Screw Mini | Ø3.2mm | 0 | 5.0mm |
| K2100080 | 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 | ||||
| K210080 | s-Celan (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 | ||||
| K210080 | s-Celan (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 | ||||
| K210080 | s-Celan (TiN Half Coating) | |||
| Angled Abutment Mini | Ø4.0 and 4.5 | 15 | 12.09, 12.34, 12.51 and 12.76 |
Denis s-Clean SQ-SL Fixture is provided sterilized.
Dentis s-Clean SQ-SL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.
This document is a 510(k) Summary for the Dentis s-Clean SQ-SL Fixture, a dental implant. It does not contain information about the acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective. The document focuses on establishing substantial equivalence to predicate devices through non-clinical testing.
Therefore, I cannot provide the requested information regarding AI/algorithm acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.
The "Non-Clinical Test Data" section describes engineering and biocompatibility tests conducted on the device, not an AI algorithm.
Non-Clinical Test Data Summary (from the document):
- Tests performed on the subject device: Fatigue Testing (ISO 14801:2016).
- Tests performed on predicate devices and leveraged for the subject device:
- Sterilization Validation Test on Fixtures (ISO 11137-1,2,3 referenced in K192688).
- Shelf-Life Test on Fixtures (ASTM F1980 referenced in K153639).
- Biocompatibility testing on fixtures (ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K153639).
- Bacterial Endotoxin Test Report on Fixtures (ANSI/AAMI ST72:2011, USP , and USP referenced in K192688).
- Acceptance Criteria for these non-clinical tests: "met the criteria of the standards" (e.g., ISO 14801:2016 for fatigue).
- Study Design/Purpose: To demonstrate substantial equivalence to predicate devices.
- MR Environment Condition: A non-clinical worst-case MRI review was performed using scientific rationale and published literature to evaluate magnetic safety, addressing magnetically induced displacement force and torque.
This document describes a traditional medical device (dental implant) clearance process, not one involving Artificial Intelligence.
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