The following data is part of a premarket notification filed by American Dental Products, Inc. with the FDA for American Dental Products (adp), Fluoride Releasing Glass Ionomer Band Cement.
| Device ID | K950512 |
| 510k Number | K950512 |
| Device Name: | AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENT |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | AMERICAN DENTAL PRODUCTS, INC. P.O. BOX 435 Medinah, IL 60157 -0435 |
| Contact | George Nicoae |
| Correspondent | George Nicoae AMERICAN DENTAL PRODUCTS, INC. P.O. BOX 435 Medinah, IL 60157 -0435 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-03-07 |