PULPDENT POLYAMIDE DENTIN LINER
FDA 510(k) clearance K911285 · decided 1991-10-09
Clearance details
- K-number
- K911285
- Device name
- PULPDENT POLYAMIDE DENTIN LINER
- Applicant
- Pulpdent Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-19
- Decision date
- 1991-10-09
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- EME
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Watertown, MA, 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 |
|---|---|---|
| BIOPSY PUNCH, SURGICAL (K933670) | Byron Medical | 1994-01-07 |
| EURO-MED LIGHT TOUCH BIOPSY PUNCH (K884740) | Buckman Co., Inc. | 1989-03-06 |
Recalls involving this device
No recalls on record reference this clearance.