KZP · Solution, Cement Dissolving
Dental · 21 CFR 872.3750 · Class 2
Overview
| Product Code | KZP |
|---|---|
| Device Name | Solution, Cement Dissolving |
| Regulation | 21 CFR 872.3750 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K920843 | TOOTH CONDITIONER | Confi-Dental Products Co. | Apr 8, 1993 | SESE |
| K771974 | SOLVENEX I-0 | Den-Mat Corp. | Jan 12, 1978 | SESE |
Top Applicants
- Den-Mat Corp. — 1 clearance
- Confi-Dental Products Co. — 1 clearance
