The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for 2 Bond 2.
| Device ID | K971733 |
| 510k Number | K971733 |
| Device Name: | 2 BOND 2 |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. Irvine, CA 92718 -2595 |
| Contact | Sharon Parker |
| Correspondent | Sharon Parker HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. Irvine, CA 92718 -2595 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-09 |
| Decision Date | 1997-10-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() 2 BOND 2 75221658 2215733 Dead/Cancelled |
Heraeus Kulzer GmbH 1997-01-06 |