NEW GEAR RELEASABLE HEADGEAR
Device Facts
| Record ID | K940410 |
|---|---|
| Device Name | NEW GEAR RELEASABLE HEADGEAR |
| Applicant | Ortho Kinetics Corp. |
| Product Code | DZB · Dental |
| Decision Date | Mar 10, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.5500 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.
