EEF · Clamp, Rubber Dam
Dental · 21 CFR 872.6300 · Class 1
Overview
| Product Code | EEF |
|---|---|
| Device Name | Clamp, Rubber Dam |
| Regulation | 21 CFR 872.6300 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K071615 | FIXAFLOSS | Sybron Dental Specialties, Inc. | Sep 21, 2007 | SESE |
| K915207 | DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP | Bay Technical Products, Inc. | Feb 14, 1992 | SESE |
| K780744 | BRINKER TISSUE RETRACTORS | Hygienic Dental Mfg., Co., The | May 12, 1978 | SESE |
Top Applicants
- Sybron Dental Specialties, Inc. — 1 clearance
- Hygienic Dental Mfg., Co., The — 1 clearance
- Bay Technical Products, Inc. — 1 clearance
