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 |