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 |