(88 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.