EXPLORER TIP
FDA 510(k) clearance K823914 · decided 1983-01-21
Clearance details
- K-number
- K823914
- Device name
- EXPLORER TIP
- Applicant
- Treace Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-28
- Decision date
- 1983-01-21
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- EKB
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Walker, MI, 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 |
|---|---|---|
| 1410/1 TO 1435/13 VARIOUS PROBES & EXPLORERS (K851724) | Artiberia | 1985-07-02 |
| BEACH EXPLORER NO. 23T.G. (K821780) | Pacific Dental Corp. | 1982-07-06 |
Recalls involving this device
No recalls on record reference this clearance.