Aira 600118
by Aira, LLC
Aira 600118 is a Class II device made by Aira, LLC, cleared under FDA 510(k) K230487 on 3 Jul 2023 and listed in FDA GUDID since 26 Aug 2026 (UDI-DI 00810194402081), active 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 | Number00810194402081 | Date26 Aug 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230487 | Date3 Jul 2023 | StatusActive |
Official records
- AccessGUDID record 00810194402081
- FDA 510(k) database K230487
Across registries
- FDA 510(k) K230487 decided 3 Jul 2023 Active
- FDA GUDID UDI-DI 00810194402081 listed 26 Aug 2026 Listed
Timeline
- Cleared FDA 510(k) K230487
- Listed FDA GUDID 00810194402081
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aira
- Generic name
- Dental appliance fabrication material, ceramic
- Model / reference
- 600118
- Primary DI / UDI-DI
- 00810194402081
- 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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