The following data is part of a premarket notification filed by American Dental Products, Inc. with the FDA for American Dental Products Tissue Conditioner & Temporary Reliner.
| Device ID | K954637 |
| 510k Number | K954637 |
| Device Name: | AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-06 |
| Decision Date | 1995-12-28 |