The following data is part of a premarket notification filed by American Dental Products, Inc. with the FDA for American Dental Prodducts Light Activated Composite Resin Core Paste With Fluoride.
| Device ID | K954405 |
| 510k Number | K954405 |
| Device Name: | AMERICAN DENTAL PRODDUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE PASTE WITH FLUORIDE |
| 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 | 1995-09-20 |
| Decision Date | 1995-10-30 |