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 |