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 |