S-Clean OneQ-SL Narrow Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161244 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 OneQ-SL Narrow Implant System is a bone level dental implant designed for clinical use. It features an internal connection with a 22-degree Morse taper and a hexagonal interface, utilizing a tapered body with V-shaped threads and a straight head.
This device is supplied as part of the S-Clean implant system and is intended for dental applications. It has received FDA 510k clearance under K161244. The system is available in a narrow platform configuration to support prosthetic versatility and primary stability.
Frequently asked questions
What is the s-Clean OneQ-SL Narrow Implant System used for?
The s-Clean OneQ-SL Narrow Implant System is a bone-level dental implant designed specifically for dental applications. Its tapered body with V-shaped threads and straight head, combined with an internal 22-degree Morse taper and hexagonal interface, provides enhanced primary stability and support for prosthetic versatility. This makes it ideal for restoring single or multiple missing teeth by integrating directly into the jawbone.
How is the s-Clean OneQ-SL Narrow Implant System supplied?
This implant system is supplied as part of the broader S-Clean implant system. It is available in a narrow platform configuration, which is tailored to accommodate various prosthetic options while ensuring optimal stability during placement. The system is designed to be used in clinical settings by dental professionals.
Is the s-Clean OneQ-SL Narrow Implant System single-use or reusable?
The s-Clean OneQ-SL Narrow Implant System is intended for single-use in clinical settings. Dental implants are typically designed for one-time placement to ensure patient safety and sterility. Reusing implants could compromise integrity and increase infection risks, which is why this system follows standard single-use protocols.
What distinguishes the s-Clean OneQ-SL Narrow Implant System from other dental implants?
This implant features a unique combination of an internal 22-degree Morse taper and a hexagonal interface, which enhances stability and connection strength. Additionally, its narrow platform design supports greater prosthetic flexibility, making it suitable for a wider range of restorative options compared to standard implants. The V-shaped threads further improve osseointegration with the surrounding bone.
How should the s-Clean OneQ-SL Narrow Implant System be stored?
The s-Clean OneQ-SL Narrow Implant System should be stored in a clean, dry environment protected from moisture, dust, and direct sunlight. It is critical to maintain sterility until use, as dental implants must remain uncontaminated to prevent infection. Follow the manufacturer’s guidelines for packaging integrity and expiration dates to ensure optimal performance and safety.
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: OneQ - Dentis USA, s-Clean Implant System - Dentis USA, Dentis OneQ-SL Dental Implant | SpotImplant, S-Clean - Dentis Europe
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161244 | Class II | Active |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
- FDA Applicant
- Dentis Co., Ltd.
Sources (1)
- FDA 510(k) K161244 24 fields · synced Oct 1, 2026