PLANUSTAR AND DENS NOBILIS DENTURE TEETH
FDA 510(k) clearance K912989 · decided 1991-08-16
Clearance details
- K-number
- K912989
- Device name
- PLANUSTAR AND DENS NOBILIS DENTURE TEETH
- Applicant
- Wilde-USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-07-08
- Decision date
- 1991-08-16
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- EMI
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Naperville, 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 |
|---|---|---|
| MINI-MILL (K914035) | Biomedical Composites, Ltd. | 1992-03-02 |
| 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES (K851716) | Artiberia | 1985-06-11 |
| DISC NEEDLE SET #TX-8220 (K823676) | Today'S Machining & Design, Inc. | 1983-01-09 |
Recalls involving this device
No recalls on record reference this clearance.