The following data is part of a premarket notification filed by American Dental Products, Inc. with the FDA for American Dental Products Root Canal Sealer, Wach's Formula.
| Device ID | K954876 |
| 510k Number | K954876 |
| Device Name: | AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA |
| Classification | Cement, Dental |
| Applicant | AMERICAN DENTAL PRODUCTS, INC. P.O. BOX 435 Medinah, IL 60157 -0435 |
| Contact | George Nicolae |
| Correspondent | George Nicolae AMERICAN DENTAL PRODUCTS, INC. P.O. BOX 435 Medinah, IL 60157 -0435 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-24 |
| Decision Date | 1995-11-15 |