TOOTH CONDITIONER
FDA 510(k) clearance K920843 · decided 1993-04-08
Clearance details
- K-number
- K920843
- Device name
- TOOTH CONDITIONER
- Applicant
- Confi-Dental Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-02-25
- Decision date
- 1993-04-08
- Days to decision
- 408 days
- Clearance type
- Traditional
- Product code
- KZP
- Device class
- 2
- Regulation number
- 872.3750
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Louisville, CO, 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 |
|---|---|---|
| SOLVENEX I-0 (K771974) | Den-Mat Corp. | 1978-01-12 |
Recalls involving this device
No recalls on record reference this clearance.