The following data is part of a premarket notification filed by Belport Company, Inc., Gingi-pak with the FDA for Etchpro Etching Gel.
| Device ID | K200462 |
| 510k Number | K200462 |
| Device Name: | EtchPro Etching Gel |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Belport Company, Inc., Gingi-Pak 4825 Calle Alto, Camarillo, CA 93012 |
| Contact | Daniel Wang |
| Correspondent | Daisy Ni Belport Company, Inc., Gingi-Pak 4825 Calle Alto, Camarillo, CA 93012 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-25 |
| Decision Date | 2020-09-02 |