The following data is part of a premarket notification filed by E&d Dental Products, Inc. with the FDA for Revolution Bond.
Device ID | K953592 |
510k Number | K953592 |
Device Name: | REVOLUTION BOND |
Classification | Agent, Tooth Bonding, Resin |
Applicant | E&D DENTAL PRODUCTS, INC. 71 VERONICA AVE. SUITE 3 Somerset, NJ 08873 |
Contact | Ed Spehar |
Correspondent | Ed Spehar E&D DENTAL PRODUCTS, INC. 71 VERONICA AVE. SUITE 3 Somerset, NJ 08873 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-01 |
Decision Date | 1995-09-07 |