G-Block GB00001
G-Block GB00001 is a Class II device made by Graphenano Dental Sl., cleared under FDA 510(k) K253236 on 29 Sep 2025 and listed in FDA GUDID since 13 Jan 2026 (UDI-DI 08445644003215), active as of 23 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 | Number08445644003215 | Date13 Jan 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK253236 | Date29 Sep 2025 | StatusActive |
Official records
- AccessGUDID record 08445644003215
- FDA 510(k) database K253236
Across registries
- FDA 510(k) K253236 decided 29 Sep 2025 Active
- FDA GUDID UDI-DI 08445644003215 listed 13 Jan 2026 Listed
Timeline
- Cleared FDA 510(k) K253236
- Listed FDA GUDID 08445644003215
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- G-Block
- Generic name
- Dental appliance fabrication material, thermoplastic
- Model / reference
- GB00001
- Primary DI / UDI-DI
- 08445644003215
- 510(k) Number
- FDA product code
- EBF, EBG
- GMDN term
- Dental appliance fabrication material, thermoplastic
- Device class
- Class II
- Regulation number
- 872.3690, 872.3770
- GUDID distribution status
- In Commercial Distribution
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