The following data is part of a premarket notification filed by American Dental Products, Inc. with the FDA for American Dental Products Orthodontic Adhesive W/one Step Bonding System.
| Device ID | K954333 |
| 510k Number | K954333 |
| Device Name: | AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| 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 | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-18 |
| Decision Date | 1995-10-12 |