G-Cam GC00010
G-Cam GC00010 is a Class II device made by Graphenano Dental Sl., cleared under FDA 510(k) K220329 on 16 Aug 2022 and listed in FDA GUDID since 21 Oct 2022 (UDI-DI 08445644000924), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08445644000924 | Date21 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220329 | Date16 Aug 2022 | StatusActive |
Official records
- AccessGUDID record 08445644000924
- FDA 510(k) database K220329
Across registries
- FDA 510(k) K220329 decided 16 Aug 2022 Active
- FDA GUDID UDI-DI 08445644000924 listed 21 Oct 2022 Listed
Recalls
-
- Ongoing Z-1192-2024
Machining error on cams renders the device unusable.
Timeline
- Cleared FDA 510(k) K220329
- Listed FDA GUDID 08445644000924
- Recall initiated FDA recalls Z-1192-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- G-Cam
- Generic name
- Dental appliance fabrication material, thermoplastic
- Model / reference
- GC00010
- Primary DI / UDI-DI
- 08445644000924
- 510(k) Number
- FDA product code
- EBF, EBG, EBI
- GMDN term
- Dental appliance fabrication material, thermoplastic
- Device class
- Class II
- Regulation number
- 872.3690, 872.3770, 872.3760
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Dental appliance fabrication material, thermoplastic.