The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Charisma F, Charisma Creactive, Solid Bond, & Esticid -20fg.
| Device ID | K964038 |
| 510k Number | K964038 |
| Device Name: | CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Contact | Cheryl Zimmerman |
| Correspondent | Cheryl 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 | 1996-10-04 |
| Decision Date | 1997-04-02 |