BELMONT QUOLIS 5000 SERIES DENTAL UNIT
FDA 510(k) clearance K072273 · decided 2007-12-20
Clearance details
- K-number
- K072273
- Device name
- BELMONT QUOLIS 5000 SERIES DENTAL UNIT
- Applicant
- Takara Belmont USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-15
- Decision date
- 2007-12-20
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- NRD
- Device class
- 1
- Regulation number
- 872.6640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- West Cadwell, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ACCLAIM (K042266) | Air Techniques, Inc. | 2004-08-31 |
Recalls involving this device
No recalls on record reference this clearance.