Identifiers
- 510(k) Number
- K961199 FDA 510(k)
- FDA Product Code
- EBG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3770 FDA 510(k)
- Regulation Number
- 872.3770 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bosworth Temporary Resin is a dental device, classified as a Crown And Bridge, Temporary, Resin. It is used in dental applications, specifically for temporary crowns and bridges.
The device is supplied by Harry J. Bosworth Co. and has been cleared by the FDA with a 510K clearance, K961199. It has a product code of EBG and is classified as a Class II device with special controls. The device is intended for dental use, and its storage and handling are subject to standard dental protocols.
Frequently asked questions
What is the Bosworth Temporary Resin used for?
The Bosworth Temporary Resin is used in dental applications, specifically for temporary crowns and bridges, following standard dental protocols.
How is the Bosworth Temporary Resin supplied?
The device is supplied by Harry J. Bosworth Co., with storage and handling subject to standard dental protocols.
What is the regulatory status of the Bosworth Temporary Resin?
The Bosworth Temporary Resin has been cleared by the FDA with a 510K clearance, K961199, and is classified as a Class II device with special controls.
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: BOSWORTH TEMPORARY RESIN (K961199) — FDA 510 (k) | Innolitics, K961199 - BOSWORTH TEMPORARY RESIN | FDA 510 (k), K961199 - Crown And Bridge, Temporary, Resin FDA 510 (k) APPLICATION ..., PDF K961199 - Bosworth Temporary Resin, Trim® and Trim® II PEMA Temporary Resin Acrylic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K961199 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Harry J. Bosworth Co.
Sources (1)
- FDA 510(k) K961199 24 fields · synced Oct 6, 2026