Pulpdent Temporary Crown and Bridge Material
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081810 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)
This device is a dental temporary crown and bridge material, classified as a resin composite. It is designed as a temporary prosthesis to restore missing or damaged teeth while a permanent restoration is fabricated, providing structural support and aesthetic appearance during the interim period.
The material is supplied as a dual-cure, glass-filled resin composite intended for use by dental professionals. It is classified under FDA product code EBG and received FDA 510(k) clearance as substantially equivalent to a predicate device. The material is not described as single-use or reusable in the regulatory data, and no specific sterility or MRI safety information is provided.
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: Pulpdent Temporary Crown and Bridge Material, PDF PULPDENT CORPORA TION SEP 1 72008 - accessdata.fda.gov, Crowns and Bridges - PULPDENT, PDF PULPDENT Crown and Bridge Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081810 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K081810 24 fields · synced Sep 18, 2026