865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES
FDA 510(k) clearance K851716 · decided 1985-06-11
Clearance details
- K-number
- K851716
- Device name
- 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES
- Applicant
- Artiberia
- Decision
- Substantially Equivalent
- Date received
- 1985-04-25
- Decision date
- 1985-06-11
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- EMI
- 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 |
|---|---|---|
| MINI-MILL (K914035) | Biomedical Composites, Ltd. | 1992-03-02 |
| PLANUSTAR AND DENS NOBILIS DENTURE TEETH (K912989) | Wilde-USA, Inc. | 1991-08-16 |
| 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.