CLINI-DENT
FDA 510(k) clearance K000140 · decided 2000-05-03
Clearance details
- K-number
- K000140
- Device name
- CLINI-DENT
- Applicant
- The Precident Group
- Decision
- Substantially Equivalent
- Date received
- 2000-01-18
- Decision date
- 2000-05-03
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- MAU
- Device class
- 1
- Regulation number
- 872.6855
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Durham, NC, 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 |
|---|---|---|
| SMYLON (DENTAL STAIN ERASER) (K891338) | The Smylon Co. | 1989-11-14 |
Recalls involving this device
No recalls on record reference this clearance.