The following data is part of a premarket notification filed by E&d Dental Products, Inc. with the FDA for Cavi-zyme.
| Device ID | K922633 |
| 510k Number | K922633 |
| Device Name: | CAVI-ZYME |
| Classification | Handle, Instrument, Dental |
| Applicant | E&D DENTAL PRODUCTS, INC. 560 SPRINGFIELD AVE. SUITE 1B Westfield, NJ 07090 |
| Contact | Ed Spehar |
| Correspondent | Ed Spehar E&D DENTAL PRODUCTS, INC. 560 SPRINGFIELD AVE. SUITE 1B Westfield, NJ 07090 |
| Product Code | EJB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-20 |
| Decision Date | 1992-08-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CAVI-ZYME 74369989 1806983 Dead/Cancelled |
E & D DENTAL PRODUCTS, INC. 1993-03-22 |