The following data is part of a premarket notification filed by Pulpdent Corp. Of America with the FDA for Acid Etch Gel.
| Device ID | K882576 |
| 510k Number | K882576 |
| Device Name: | ACID ETCH GEL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PULPDENT CORP. OF AMERICA 75 BOYLSTON ST. P.O. BOX 689 Brookline, MA 02147 |
| Contact | Kenneth Berk |
| Correspondent | Kenneth Berk PULPDENT CORP. OF AMERICA 75 BOYLSTON ST. P.O. BOX 689 Brookline, MA 02147 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-22 |
| Decision Date | 1988-07-15 |