MacBite 12178
by Surgimac LLC
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD105121781 | Date15 Aug 2025 | StatusListed |
| United States | FDA 510(k) | NumberK221668 | Date8 Aug 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MacBite
- Generic name
- Silicone dental impression material
- Model / reference
- 12178
- Primary DI / UDI-DI
- D105121781
- 510(k) Number
- FDA product code
- ELW
- GMDN term
- Silicone dental impression material
- Device class
- Class II
- Regulation number
- 872.3660
- GUDID distribution status
- In Commercial Distribution
Other devices from Surgimac LLC
Properties
Other properties (11)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Prescription use: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Lot / batch number: No
- Serial number: No