Flight Dental Systems Clave28+
by Flight Dental Systems USA Inc.
Flight Dental Systems Clave28+ is a steam sterilizer (FDA Class II; FDA product code FLE, Sterilizer, Steam) made by Flight Dental Systems USA Inc., cleared under FDA 510(k) K243994 on 6 Jun 2025 and listed in FDA GUDID since 18 Jul 2025 (UDI-DI D178CLAVE28), 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 | NumberD178CLAVE28 | Date18 Jul 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243994 | Date6 Jun 2025 | StatusActive |
Official records
- FDA 510(k) database K243994
Across registries
- FDA 510(k) K243994 decided 6 Jun 2025 Active
- FDA GUDID UDI-DI D178CLAVE28 listed 18 Jul 2025 Listed
Timeline
- Cleared FDA 510(k) K243994
- Listed FDA GUDID D178CLAVE28
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flight Dental Systems
- Generic name
- Steam sterilizer
- Model / Ref / Catalog
- Clave28+
- Primary DI / UDI-DI
- D178CLAVE28
- 510(k) Number
- FDA product code
- FLE
- GMDN term
- Steam sterilizer
- Device class
- Class II
- Regulation number
- 880.6880
- GUDID distribution status
- In Commercial Distribution
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