The following data is part of a premarket notification filed by Pac-dent, Inc. with the FDA for Pacbond One.
| Device ID | K210186 |
| 510k Number | K210186 |
| Device Name: | PacBond One |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Pac-Dent, Inc. 670 Endeavor Circle Brea, CA 92821 |
| Contact | Tom Peng |
| Correspondent | Tom Peng Pac-Dent, Inc. 670 Endeavor Circle Brea, CA 92821 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-25 |
| Decision Date | 2021-07-16 |