BRITESMILE BARRIER MATERIAL
Device Facts
| Record ID | K010935 |
|---|---|
| Device Name | BRITESMILE BARRIER MATERIAL |
| Applicant | Britesmile, Inc. |
| Product Code | EIE · Dental |
| Decision Date | Sep 5, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6300 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.
