The following data is part of a premarket notification filed by Pulpdent Corp. with the FDA for 9.6% Hydrofluoric Acid Gel.
| Device ID | K896655 |
| 510k Number | K896655 |
| Device Name: | 9.6% HYDROFLUORIC ACID GEL |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02471 -0780 |
| Contact | Kenneth J Berk |
| Correspondent | Kenneth J Berk PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02471 -0780 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-24 |
| Decision Date | 1990-02-14 |