CAVI-ZYME
FDA 510(k) clearance K922633 · decided 1992-08-06
Clearance details
- K-number
- K922633
- Device name
- CAVI-ZYME
- Applicant
- E&D Dental Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-20
- Decision date
- 1992-08-06
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- EJB
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Westfield, NJ, 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 |
|---|---|---|
| BENDA WEDGE (K140144) | Centrix, Inc. | 2014-07-08 |
| DETECTAR, MODEL N123-MI (K023367) | Neks Technologies | 2003-06-25 |
| FLARE,FILE, FILL (K981234) | Lone Star Technologies | 1998-06-05 |
| AUKUSLEEVE (K930094) | Aukland Medical Plastics, Inc. | 1993-10-20 |
| SPATULA, DENTAL, CEMENT (K871818) | Military Engineering, Inc. | 1987-07-02 |
| TOOTH SLOOTH (K833338) | Joel Lander D.D.S. | 1983-11-25 |
| SOFT GRIP UNI-HANDLE (K823913) | Treace Medical, Inc. | 1983-01-26 |
Recalls involving this device
No recalls on record reference this clearance.