DENTAL DAM SILICONE

K961472 · Worldwide Dental, Inc. · EIE · Aug 7, 1996 · Dental

Device Facts

• Record ID: K961472
• Device Name: DENTAL DAM SILICONE
• Applicant: Worldwide Dental, Inc.
• Product Code: EIE · Dental
• Decision Date: Aug 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6300
• Device Class: Class 1

Indications for Use

The Roeko silicone dam is intended for use as a physical barrier around a tooth to allow isolation from fluids in the mouth during dental procedures. The tooth is isolated by insertion through a hole punched in the center of the silicone sheet. The dental dam is inserted into the oral cavity using frame and clamp accessories.

Device Story

Silicone dental dam; 150 mm x 150 mm green opaque film; <1mm thickness. Used as physical barrier for tooth isolation during dental procedures. Inserted into oral cavity via hole punched in sheet; secured with frame and clamp accessories. Provides alternative for latex-allergic patients and clinicians. Benefits include biocompatibility and slow aging process compared to latex.

Clinical Evidence

Bench testing only; biocompatibility testing performed to assess biological response.

Technological Characteristics

Polymerized silicone film; contains catalyst and coloring agent. Dimensions: 150 mm x 150 mm; thickness <1mm. Physical properties (elongation) comparable to latex. Non-latex material composition.

Indications for Use

Indicated for use as a physical barrier for tooth isolation from oral fluids during dental procedures. Suitable for patients and dental professionals with latex allergies.

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.

Predicate Devices

• Hygienic brand latex dam

Submission Summary (Full Text)

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K 961472

AUG - 7 1996

510(k)Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. The submitter of this premarket notification is:
Karen K. Vaccaro, Ph.D.
EXPERTech™ Associates, Inc.
100 Main Street, Suite 120
Concord, MA 01742-5307
Telephone: [phone]
Fax: [phone]

This Summary was prepared on July 24, 1996.

2. The name of the device is Roeko Dental Dam Silicone. Its common name is dental dam and the classification name is Rubber dam and accessories.

3. The Roeko Silicone Dental Dam is substantially equivalent to the Hygienic brand latex dam.

4. The Roeko dam is a silicone product used in dental procedures. The device consists of a 150 mm x 150 mm green opaque film of less than 1mm in thickness. The device is available with frame, clamp and other accessories for use in dental procedures.

5. The Roeko silicone dam is intended for use as a physical barrier around a tooth to allow isolation from fluids in the mouth during dental procedures. The tooth is isolated by insertion through a hole punched in the center of the silicone sheet. The dental dam is inserted into the oral cavity using frame and clamp accessories. These indications are the same as those claimed for the predicate device.

6. The technological characteristics in terms of physical properties, particularly elongation, are comparable to latex; however, the aging process is very slow, if at all. Chemically, the Roeko dental dam is composed of polymerized silicone rather than latex and contains a catalyst and coloring agent. Biocompatibility tests indicate that Roeko Dental Dam Silicone does not show significantly adverse biological responses. Patients with a latex allergy can now be treated with a silicone dental dam and dentists allergic to latex are able to treat patients with a silicone dental dam. In view of the above, the device is as safe, as effective and performs as well or better than the predicate device.