Identifiers
- 510(k) Number
- K761355 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Selfast is a dental cement used in dental procedures. It is classified as a dental cement under the dental medical specialty.
This device is authorized for use under FDA 510(k) clearance. It is supplied by Septodont, Inc. and is categorized under regulation number 872.3275.
Frequently asked questions
What is the primary use of Selfast?
Selfast is a dental cement specifically indicated for use in dental procedures within the dental medical specialty.
Who is the manufacturer of this dental cement?
Selfast is supplied by Septodont, Inc., which is located in McHenry, Illinois.
What is the regulatory status of Selfast?
This device is authorized for use under FDA 510(k) clearance, having been determined to be substantially equivalent to other devices under regulation number 872.3275.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K761355 | Class II | Active |
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Manufacturer
- Manufacturer
- Septodont, Inc
- FDA Applicant
- Septodont, Inc.
Sources (1)
- FDA 510(k) K761355 24 fields · synced Sep 21, 2026