UltraPrint-Dental Temp C&B UV
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213643 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 UltraPrint-Dental Temp C&B UV is a dental 3D printing resin designed for manufacturing temporary crowns and bridges. Classified under product code EBG, this material is formulated for use in digital dentistry workflows, offering enhanced mechanical properties such as pressure and impact resistance, wear resistance, and corrosion resistance. Its composition ensures excellent marginal adaptation and dimensional stability for temporary restorations.
This device is supplied in 500g bottles and is intended for use with compatible DLP 3D printers in a closed-loop digital-dentistry workflow. It has received FDA 510(k) clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent) and advisory committee review by the Dental Expert Panel (DE). The material is not explicitly stated as single-use or reusable, but its application in temporary restorations typically aligns with single-patient use. No specific sterility or MRI safety information is provided in the available data.
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: Temp C&B UV 2.0 - 3D Printing Materials - HeyGears, HEYGears - UltraPrint-Dental Temp C&B UV - BL (Bleach)，500g/bottle (HD ..., GUANGZHOU HEYGEARS IMC.INC 2.0 UltraPrint-Dental Temp C&B UV
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213643 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangzhou Heygears Imc.inc
- FDA Applicant
- Guangzhou Heygears IMC., Inc.
Sources (1)
- FDA 510(k) K213643 24 fields · synced Sep 18, 2026