PREMIER CARVERS, STYLE #21C & 21D
FDA 510(k) clearance K780528 · decided 1978-04-19
Clearance details
- K-number
- K780528
- Device name
- PREMIER CARVERS, STYLE #21C & 21D
- Applicant
- Premier Dental Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-04-03
- Decision date
- 1978-04-19
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- EKH
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, 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 |
|---|---|---|
| DENTAL INSTRUMENTS - CARVER (K823321) | Miltex, Inc. | 1982-11-24 |
| BEACH AMALGAM CARVER (K821785) | Pacific Dental Corp. | 1982-07-06 |
Recalls involving this device
No recalls on record reference this clearance.