NRD
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Unit, Operative Dental, Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6640
- Medical specialty
- Dental
- FDA definition
- Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BELMONT QUOLIS 5000 SERIES DENTAL UNIT (K072273) | Takara Belmont USA, Inc. | 2007-12-20 |
| ACCLAIM (K042266) | Air Techniques, Inc. | 2004-08-31 |
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Every clearance here is in the API, with alerts when new ones post.