DENTAL HANDPIECE AND ACCESSORY

K963664 · Filmtech, Inc. · EFB · Oct 24, 1996 · Dental

Device Facts

• Record ID: K963664
• Device Name: DENTAL HANDPIECE AND ACCESSORY
• Applicant: Filmtech, Inc.
• Product Code: EFB · Dental
• Decision Date: Oct 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

Brixton Infection Control Barrier is intended as a single use, transparent plastic, disposable, nonsterile barrier that will help reduce gross contamination and provide equipment surface protection for devices used within the dental/ clinical treatment setting. Brixton Infection Control Barriers are available in an assortment of sizes and shapes, designed to accommodate the following types of equipment: Light Handles Chairs Headrests Air and Water Syringe sleeves (ties included) Stools X-Ray Heads Trays

Device Story

Single-use, transparent, polyethylene plastic barrier; designed to cover dental/clinical equipment surfaces; reduces gross contamination and cross-contamination; available in various sizes/shapes; dispensed in boxes of 200, 250, or 500; used by dental/clinical staff to protect equipment during patient treatment.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Polyethylene plastic. Form factor: Disposable, transparent covers in various sizes/shapes. Non-sterile. Single-use.

Indications for Use

Indicated for use in dental and clinical settings to provide surface protection and reduce cross-contamination of equipment, including light handles, chairs, headrests, air/water syringe sleeves, stools, X-ray heads, and trays.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

• Disposa-Shield Infection Control Barrier (K900093)
• Barrier All Film (K952234)

Submission Summary (Full Text)

{0}

OCT 24 1996
K963664

# VI. 510 K Summary for Brixton Barrier Products

## I. Submitted by

Filmtech, Inc.
581 McDonald Ave
Brooklyn, N.Y. 11218
[phone]

**Contact Person**
Jacob Posner
Filmtech, Inc.
581 McDonald Ave
Brooklyn, N.Y. 11218
[phone]

**Consultant**
Suzanne Parisian, M.D.
Medical Device Assistance, Inc.
P.O.Box 296
Front Royal, VA 22630
[phone]

**Date Prepared**
September 6, 1996

## 2. Device Name: Brixton Infection Control Barrier

**Classification Name:** Dental Handpiece and Accessory
**FDA Classification:** Class II per 21 CFR 872.4200

## 3. Predicate Devices: Filmtech. Inc. claims substantial equivalence for their Brixton Infection Control Barrier to K900093 Dentsply International Inc.’s Disposa-Shield Infection Control Barrier and K952234 Cottrell, Ltd.’s Barrier All Film.

## 4. Intended Use: Brixton Infection Control Barrier is intended as a single use, transparent plastic, disposable, nonsterile barrier that will help reduce gross contamination and provide equipment surface protection for devices used within the dental/ clinical treatment setting. Brixton Infection Control Barriers are available in an assortment of sizes and shapes, designed to accommodate the following types of equipment:

- *Light Handles*

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* Chairs
* Headrests
* Air and Water Syringe sleeves (ties included)
* Stools
* X-Ray Heads
* Trays

5. Device Description/ Technological Characteristics

The Brixton Infection Control Barrier manufactured by Filmtech, Inc. is intended as a single use, disposable, transparent, polyethylene plastic equipment cover that will help provide surface protection and reduce cross contamination of equipment used in the dental/ clinical setting. The barriers are available in a variety of sizes and shapes, dispensed in boxes containing 200, 250 or 500 covers.

6. Conclusion

The Brixton Infection Control Barrier has no significant difference that will alter the effect or raise new issues of safety and effectiveness; has substantially equivalent technological and performance characteristics as the predicate devices; and raises no new types of safety or effectiveness questions. All characteristics of the Brixton Infection Control Barriers support the finding of substantial equivalence.

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