The following data is part of a premarket notification filed by Health-dent Intl., Inc. with the FDA for Hema-benz.
Device ID | K953405 |
510k Number | K953405 |
Device Name: | HEMA-BENZ |
Classification | Agent, Tooth Bonding, Resin |
Applicant | HEALTH-DENT INTL., INC. 118 WEST LAKE ST. Northlake, IL 60164 |
Contact | Al Bevilacqua |
Correspondent | Al Bevilacqua HEALTH-DENT INTL., INC. 118 WEST LAKE ST. Northlake, IL 60164 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-20 |
Decision Date | 1995-09-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850362007076 | K953405 | 000 |
00850362007069 | K953405 | 000 |
00850362007052 | K953405 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HEMA-BENZ 77396528 3501609 Live/Registered |
HEALTHDENT'L LLC 2008-02-13 |
HEMA-BENZ 75123608 2057465 Dead/Cancelled |
Health-Dent International, Inc. 1996-06-21 |