IDENTOFLEX
FDA 510(k) clearance K771658 · decided 1977-09-12
Clearance details
- K-number
- K771658
- Device name
- IDENTOFLEX
- Applicant
- Cavitron Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-08-30
- Decision date
- 1977-09-12
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- EHJ
- Device class
- 1
- Regulation number
- 872.6010
- 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 |
|---|---|---|
| MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS (K911111) | Vermont Diamond Instruments | 1991-11-19 |
| MIN-IDENTOFLEX (K873002) | Centrix, Inc. | 1987-08-17 |
| HOWMEDICA BRASS CENTER DISC (K790640) | E.C. Moore Co. | 1979-05-01 |
Recalls involving this device
No recalls on record reference this clearance.