Cerasmart® 011958
Cerasmart® 011958 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K133824 on 14 Mar 2014 and listed in FDA GUDID since 16 Oct 2017 (UDI-DI D0470119581), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | NumberD0470119581 | Date16 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133824 | Date14 Mar 2014 | StatusActive |
Official records
- FDA 510(k) database K133824
Across registries
- FDA 510(k) K133824 decided 14 Mar 2014 Active
- FDA GUDID UDI-DI D0470119581 listed 16 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K133824
- Listed FDA GUDID D0470119581
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cerasmart®
- Generic name
- Dental implant suprastructure, permanent, preformed
- Model / Ref / Catalog
- 011958
- Primary DI / UDI-DI
- D0470119581
- 510(k) Number
- FDA product code
- EBG, EBF
- GMDN term
- Dental implant suprastructure, permanent, preformed
- Device class
- Class II
- Regulation number
- 872.3770, 872.3690
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code EBG (CROWN AND BRIDGE, TEMPORARY, RESIN).
- ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL by Wallace A. Erickson & Co.
- DD medical polymers by Dental Direkt GmbH
- TEMP. ACRYLIC by Lactong Corp.
- ANAXDENT PMMA AG MULTI BLANK B1 101/20mm 18222120 by UNION DENTAL SA
- G-CAM GC00242 by GRAPHENANO DENTAL SL.
- IDODENTINE DISC B1 MULTI 98,5/25mm 4525/B1 by UNION DENTAL SA
- G-CAM GC00277 by GRAPHENANO DENTAL SL.
- Cool Temp NATURAL 5820 by Coltène/Whaledent AG
- ACUFEX ENDOFIX BUTTON by Acufex Microsurgical, Inc.
- PROVISIONAL INLAY/ONLAY KIT by Dmg USA, Inc.