The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Gluma Conditioner.
Device ID | K964140 |
510k Number | K964140 |
Device Name: | GLUMA CONDITIONER |
Classification | Agent, Tooth Bonding, Resin |
Applicant | HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
Contact | Cheryl V Zimmerman |
Correspondent | Cheryl 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 | 1996-10-15 |
Decision Date | 1996-11-05 |