Identifiers
- 510(k) Number
- K991481 FDA 510(k)
- FDA Product Code
- EJJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3070 FDA 510(k)
- Regulation Number
- 872.3070 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Paragon is a dental alloy amalgam device. It is classified as a Class II medical device under FDA regulation number 872.3070.
The device received traditional 510(k) clearance (K991481) on August 11, 1999, after being found substantially equivalent to a predicate device. It is manufactured by Lancer Orthodontics, Inc. in San Marcos, California.
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
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991481 | Class II | Active |
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Manufacturer
- Manufacturer
- Lancer Orthodontics, Inc.
Sources (1)
- FDA 510(k) K991481 24 fields · synced Sep 23, 2026