The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Gluma Desensitizer/gluma 3 Primer.
| Device ID | K962812 |
| 510k Number | K962812 |
| Device Name: | GLUMA DESENSITIZER/GLUMA 3 PRIMER |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Contact | Cherly V Zimmerman |
| Correspondent | Cherly V Zimmerman HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-18 |
| Decision Date | 1996-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660182210 | K962812 | 000 |
| J014660018540 | K962812 | 000 |
| J014658723540 | K962812 | 000 |