Who is the manufacturer of DENTAL DAM?

The Hygenic Corp. submitted the Traditional clearance for DENTAL DAM (K954990).

What is the FDA product code for DENTAL DAM?

EIE. It is classified under 21 CFR 872.6300 as a Class 1 device in the Dental panel.

What is the regulatory pathway for DENTAL DAM?

510(k) clearance (submission type: Traditional).

DENTAL DAM

K954990 · The Hygenic Corp. · EIE · Jan 26, 1996 · Dental

Device Facts

Record ID	K954990
Device Name	DENTAL DAM
Applicant	The Hygenic Corp.
Product Code	EIE · Dental
Decision Date	Jan 26, 1996
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.