Hc Primer Y0005
Hc Primer Y0005 is a dental prosthesis priming agent (FDA Class II; FDA product code KLE, Agent, Tooth Bonding, Resin) made by Shofu Dental Corp., cleared under FDA 510(k) K161891 on 21 Nov 2016 and listed in FDA GUDID since 3 Feb 2021 (UDI-DI E235Y00050), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberE235Y00050 | Date3 Feb 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161891 | Date21 Nov 2016 | StatusActive |
Official records
- FDA 510(k) database K161891
Across registries
- FDA 510(k) K161891 decided 21 Nov 2016 Active
- FDA GUDID UDI-DI E235Y00050 listed 3 Feb 2021 Listed
Timeline
- Cleared FDA 510(k) K161891
- Listed FDA GUDID E235Y00050
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hc Primer
- Generic name
- Dental prosthesis priming agent
- Model / Ref / Catalog
- Y0005
- Primary DI / UDI-DI
- E235Y00050
- 510(k) Number
- FDA product code
- KLE
- GMDN term
- Dental prosthesis priming agent
- Device class
- Class II
- Regulation number
- 872.3200
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code KLE (AGENT, TOOTH BONDING, RESIN).
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- PVS DUAL CURE VENEER BONDING KIT by Jelenko Co.
- All-Bond Universal w/BAC (not finalized) by BISCO INC.
- Prime&Bond® XP 693002 by Dentsply International
- FLUORIDE-PSA PRIME/ADHESIVE by Dentsply Intl.
- GLUMA DESENSITIZER/GLUMA 3 PRIMER by Heraeus Kulzer, Inc.