SOFT-WEAR HEADGEAR AND SAFETY MODULES
Device Facts
| Record ID | K932761 |
|---|---|
| Device Name | SOFT-WEAR HEADGEAR AND SAFETY MODULES |
| Applicant | Professional Positioners, Inc. |
| Product Code | DZB · Dental |
| Decision Date | Oct 7, 1993 |
| 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.
