The following data is part of a premarket notification filed by American Dental Products, Inc. with the FDA for American Dental Products (adp), Composite Restorative Material.
| Device ID | K951427 |
| 510k Number | K951427 |
| Device Name: | AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERIAL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | AMERICAN DENTAL PRODUCTS, INC. 22W246 SUNNYSIDE RD. P.O. BOX 435 Medinah, IL 60157 -0435 |
| Contact | George Nicolae |
| Correspondent | George Nicolae AMERICAN DENTAL PRODUCTS, INC. 22W246 SUNNYSIDE RD. P.O. BOX 435 Medinah, IL 60157 -0435 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-05-15 |