Identity
- Trade Name
- Flight Dental Systems FDA UDI
- Generic Name
- Steam sterilizer FDA UDI
- Device Name
- The Clave8+ from Flight Dental Systems is a compact Class S steam sterilizer designed for smaller dental, medical, and aesthetic practices. With an 8-liter chamber, it offers efficient and reliable sterilization for solid, unwrapped instruments—perfect for single-operator or mobile setups where space and simplicity are key. FDA UDI
- Model / Reference
- Clave8+ FDA UDI
- Description
- The Clave8+ from Flight Dental Systems is a compact Class S steam sterilizer designed for smaller dental, medical, and aesthetic practices. With an 8-liter chamber, it offers efficient and reliable sterilization for solid, unwrapped instruments—perfect for single-operator or mobile setups where space and simplicity are key. FDA UDI
Identifiers
- Catalog Number
- Clave8+ FDA UDI
- Primary DI / UDI-DI
- D178CLAVE8 FDA UDI
- 510(k) Number
- K243994 FDA UDI
- FDA Product Code
- FLE FDA UDI
- GMDN Term
- Steam sterilizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Steam sterilizer
Flight Dental Systems by Flight Dental Systems Usa Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Steam sterilizer.
- AMSCO — Steris Mexico, S. de R.L. de C.V. · Class II
- STATIM 5000 G4 Cassette Autoclave — Scican GmbH · Class II
- Integrity Sterilizers — Skytron, LLC · Class II
- Getinge 500 Series — GETINGE IC PRODUCTION POLAND SP Z O O · Class II
- PRIMUS Sterilizer — PRIMUS STERILIZER COMPANY, LLC. · Class II
- AMSCO — Steris Mexico, S. de R.L. de C.V. · Class II
- AG Neovo — ASSOCIATED INDUSTRIES CHINA, INC. · Class II
- Getinge 500 Series — GETINGE IC PRODUCTION POLAND SP Z O O · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Flight Dental Systems Usa Inc.
Sources (1)
- FDA UDI c06c882b-a6ed-4bfd-a052-1de1d71e93a1 35 fields · synced May 31, 2026