Multi M Series GAA2W16
Multi M Series GAA2W16 is a Class II device made by DMAX Co., Ltd., cleared under FDA 510(k) K250826 on 12 Jun 2025 and listed in FDA GUDID since 15 Aug 2025 (UDI-DI 08800155219379), 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 | Number08800155219379 | Date15 Aug 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK250826 | Date12 Jun 2025 | StatusActive |
Official records
- AccessGUDID record 08800155219379
- FDA 510(k) database K250826
Across registries
- FDA 510(k) K250826 decided 12 Jun 2025 Active
- FDA GUDID UDI-DI 08800155219379 listed 15 Aug 2025 Listed
Timeline
- Cleared FDA 510(k) K250826
- Listed FDA GUDID 08800155219379
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Multi M Series
- Generic name
- Dental appliance fabrication material, ceramic
- Model / reference
- GAA2W16
- Primary DI / UDI-DI
- 08800155219379
- 510(k) Number
- FDA product code
- EIH
- GMDN term
- Dental appliance fabrication material, ceramic
- Device class
- Class II
- Regulation number
- 872.6660
- GUDID distribution status
- In Commercial Distribution
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