FDA UDI
In Commercial Distribution
🇺🇸 United States
Flight Dental Systems
DI: D178CLAVE8
·
Model: Clave8+
·
Flight Dental Systems USA Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Flight Dental Systems
- Primary DI
- D178CLAVE8
- Version / Model
- Clave8+
- Catalog Number
- Clave8+
- Company Name
- Flight Dental Systems USA Inc.
- Labeler DUNS
- 119439759
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-18
- Public Version
- 1
- Public Version Date
- 2025-07-28
- Public Version Status
- New
- Public Device Record Key
- c06c882b-a6ed-4bfd-a052-1de1d71e93a1
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLE | Sterilizer, Steam | General Hospital | 880.6880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38671 | Steam sterilizer | A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D178CLAVE8 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243994 | 000 |