Identifiers
- 510(k) Number
- K121749 FDA 510(k)
- FDA Product Code
- ELM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3590 FDA 510(k)
- Regulation Number
- 872.3590 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
VERACIA is a denture, plastic, teeth device. It is substantially equivalent to a legally marketed predicate device and classified as a Class II medical device under FDA regulation 872.3590.
The device is manufactured by Shofu Dental Corporation and received FDA 510(k) clearance (K121749) on September 7, 2012. It is supplied as a finished dental prosthetic component for use in denture fabrication and is intended for prescription use by dental professionals.
Frequently asked questions
What is VERACIA used for?
VERACIA is a denture, plastic, teeth device intended for use as a finished dental prosthetic component in denture fabrication, supplied for prescription use by dental professionals to create dentures.
How is VERACIA supplied and is it sterile or single-use?
VERACIA is supplied as a finished dental prosthetic component; the data does not specify sterility or single-use status, so users should refer to the manufacturer's labeling for details on handling, sterility, and reuse.
What regulatory pathway was used for VERACIA and when was it cleared?
VERACIA received FDA 510(k) clearance under K121749 on September 7, 2012, as a substantially equivalent Class II device under regulation 872.3590, following a traditional review process.
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 | K121749 | Class II | Active |
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Manufacturer
- Manufacturer
- Shofu Dental Corporation
Sources (1)
- FDA 510(k) K121749 24 fields · synced Sep 23, 2026