s-Clean SQ-SL Implant System Regular
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192688 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The s-Clean SQ-SL Implant System Regular is a dental implant system classified as a bone-level fixture with an internal-hex connection. It features a grade-4 titanium construction and an SLA surface (sandblasted, large-grit, acid-etched), designed for osseointegration in oral and maxillofacial applications. The system is engineered to provide primary stability and prosthetic adaptability, supporting both single-tooth and multi-tooth restorations. Its Morse cone connection (22° taper) enhances mechanical retention between the implant and abutment.
This implant system is supplied as a single-use, sterile device, intended for surgical placement by dental professionals in controlled clinical settings. Available in a range of diameters (including up to 7.8 mm) and lengths (15.5 mm and 17.5 mm), it accommodates diverse anatomical requirements. The platform-narrow (P3.0, P4.2) and hexagonal interface (1.7 mm, 2.5 mm) configurations further enhance versatility. The device holds FDA 510(k) clearance (K192688) under the Dental (DZE) product code, with no third-party review involvement, and is manufactured by Dentis Co., Ltd., Daegu, South Korea.
Frequently asked questions
What is the s-Clean SQ-SL Implant System Regular designed for?
This implant system is specifically engineered for oral and maxillofacial applications, providing primary stability and prosthetic adaptability. Its bone-level fixture with an internal-hex connection and Morse cone taper (22°) ensures secure mechanical retention between the implant and abutment, supporting both single-tooth and multi-tooth restorations.
How is the s-Clean SQ-SL Implant System Regular supplied and sterilized?
The system is supplied as a single-use, sterile device, ensuring safety and consistency for surgical placement by dental professionals. Sterility is maintained through manufacturer-controlled processes, adhering to regulatory standards for medical-grade implants.
What materials and surface treatments are used in this implant system?
The s-Clean SQ-SL Implant System Regular is constructed from grade-4 titanium, a material known for its strength and biocompatibility. The surface is treated with SLA (sandblasted, large-grit, acid-etched), which enhances osseointegration—the natural bonding of bone to the implant surface—for improved long-term stability.
What sizes and configurations are available for the s-Clean SQ-SL Implant System Regular?
The system offers a range of diameters up to 7.8 mm and lengths of 15.5 mm and 17.5 mm to accommodate diverse anatomical requirements. Additionally, it includes platform-narrow (P3.0, P4.2) and hexagonal interface configurations (1.7 mm, 2.5 mm) for greater versatility in prosthetic applications.
Is the s-Clean SQ-SL Implant System Regular reusable or intended for single-use?
This implant system is explicitly designed for single-use only. Its sterile packaging and surgical-grade construction ensure optimal clinical performance and patient safety, aligning with best practices for implant dentistry to prevent cross-contamination and maintain reliability.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dentis s-Clean SQ-SL - Dental Implants Guide, S-Clean - Dentis Europe, s-Clean Implant System - Dentis USA, SQ Implant System - Dentis USA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192688 | Class II | Active |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
- FDA Applicant
- Dentis Co., Ltd.
Sources (1)
- FDA 510(k) K192688 24 fields · synced Oct 1, 2026