The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Bzf-29.
| Device ID | K200682 |
| 510k Number | K200682 |
| Device Name: | BZF-29 |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | GC America Inc. 3737 W. 127th Street Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC America Inc. 3737 W. 127th Street Alsip, IL 60803 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-16 |
| Decision Date | 2020-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0470136521 | K200682 | 000 |
| D0470136511 | K200682 | 000 |
| D0470136461 | K200682 | 000 |
| D0470136580 | K200682 | 000 |
| D0470136570 | K200682 | 000 |