OPTIFLEX
Device Facts
| Record ID | K894781 |
|---|---|
| Device Name | OPTIFLEX |
| Applicant | Ormco Corp. |
| Product Code | EJF · Dental |
| Decision Date | Sep 15, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.5410 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.
