Identifiers
- 510(k) Number
- K253324 FDA 510(k)
- FDA Product Code
- EBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3760 FDA 510(k)
- Regulation Number
- 872.3760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The UltraPrint-Dental Denture UV is a Denture Relining, Repairing, or Rebasing Resin (per 21 CFR 872.3760), designed for dental applications. This device is a photopolymer resin system used to create, repair, or reline dentures through ultraviolet (UV) curing technology, ensuring precise and durable dental restorations.
This device is supplied as a single-use resin and requires UV light exposure for curing. It is classified as Class II under FDA regulations and has received FDA 510(k) clearance (K253324) as substantially equivalent to existing dental relining and repairing resins. The product is intended for use in dental laboratories and clinics, adhering to sterility protocols for dental materials.
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: K253324 - UltraPrint-Dental Denture UV - FDA 510 (k), UltraPrint-Dental Denture UV (K253324) — FDA 510(k) | Innolitics, GUANGZHOU HEYGEARS IMC.INC 1.0 UltraPrint-Dental Denture Teeth UV
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253324 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangzhou Heygears Imc.inc
- FDA Applicant
- Guangzhou Heygears IMC., Inc.
Sources (1)
- FDA 510(k) K253324 24 fields · synced Sep 18, 2026