S-Clean Pre-Milled Abutment Mini
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210410 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The S-Clean Pre-Milled Abutment Mini is a dental abutment designed to support single or multiple tooth prostheses. It is intended for use with dental implants in the maxilla or mandible of patients who are partially or fully edentulous.
This device is intended to be used with digitally designed abutments manufactured at a Dentis validated milling center. It has received FDA 510(k) clearance under K210410.
Frequently asked questions
What is the intended use of the s-Clean Pre-Milled Abutment Mini?
This device is designed to support single or multiple tooth prostheses. It is indicated for use with dental implants in the maxilla or mandible of patients who are either partially or fully edentulous.
How must the s-Clean Pre-Milled Abutment Mini be processed?
To ensure proper fit and function, this device is intended to be used with digitally designed abutments that are manufactured specifically at a Dentis validated milling center.
What is the regulatory status of this dental abutment?
The s-Clean Pre-Milled Abutment Mini has received FDA 510(k) clearance under K210410, confirming it has been found substantially equivalent to predicate devices for its intended use.
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: s-Clean Pre-Milled Abutment Mini (K210410) — FDA 510 (k) | Innolitics, s-Clean Pre-Milled Abutment Mini - FDA 510(k) K210410, K210410 FDA 510 (k) - s-Clean Pre-Milled Abutment Mini
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210410 | Class II | Active |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
- FDA Applicant
- Dentis Co., Ltd.
Sources (1)
- FDA 510(k) K210410 24 fields · synced Sep 26, 2026