K072273 is an FDA 510(k) clearance for the BELMONT QUOLIS 5000 SERIES DENTAL UNIT. This device is classified as a Unit, Operative Dental, Accessories (Class I — General Controls, product code NRD).
Submitted by Takara Belmont USA, Inc. (West Cadwell, US). The FDA issued a Cleared decision on December 20, 2007, 127 days after receiving the submission on August 15, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640. 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..
| 510(k) Number | K072273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent — Traditional 510(k) (SESE) |
| Date Received | August 15, 2007 |
| Decision Date | December 20, 2007 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NRD — Unit, Operative Dental, Accessories |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.6640 |
| 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. |