AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
Device Facts
| Record ID | K964133 |
|---|---|
| Device Name | AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE |
| Applicant | American Dental Products, Inc. |
| Product Code | KLE · Dental |
| Decision Date | Jan 9, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3200 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.
