The following data is part of a premarket notification filed by American Dental Products, Inc. with the FDA for American Dental Products Se Bondeasy.
| Device ID | K093014 |
| 510k Number | K093014 |
| Device Name: | AMERICAN DENTAL PRODUCTS SE BONDEASY |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | AMERICAN DENTAL PRODUCTS, INC. 603-B COUNTRY CLUB DR. Bensenville, IL 60106 -1329 |
| Contact | George Nicolae |
| Correspondent | George Nicolae AMERICAN DENTAL PRODUCTS, INC. 603-B COUNTRY CLUB DR. Bensenville, IL 60106 -1329 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-29 |
| Decision Date | 2010-04-16 |
| Summary: | summary |