1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS
FDA 510(k) clearance K851723 · decided 1985-07-02
Clearance details
- K-number
- K851723
- Device name
- 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS
- Applicant
- Artiberia
- Decision
- Substantially Equivalent
- Date received
- 1985-04-25
- Decision date
- 1985-07-02
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- EKD
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Antonio, TX, 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 |
|---|---|---|
| BEACH EXCAVATOR'S NO. 1 & NO. 2 (K821790) | Pacific Dental Corp. | 1982-07-06 |
Recalls involving this device
No recalls on record reference this clearance.