(41 days)
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
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,
This document is a 510(k) summary for a medical device called the Brixton Infection Control Barrier. It details its intended use, device description, and claims of substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory submission requirements for demonstrating substantial equivalence based on device characteristics rather than reporting detailed performance studies.
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OCT 2 4 1996
VI. 510 K Summary for Brixton Barrier Products
I. Submitted by
Filmtech, Inc. 581 McDonald Ave Brooklyn, N.Y. 11218 (718) 438-8900
Contact Person
Jacob Posner Filmtech, Inc. 581 McDonald Ave Brooklyn, N.Y. 11218 (718) 438-8900
Consultant
Suzanne Parisian, M.D. Medical Device Assistance, Inc. P.O.Box 296 Front Royal, VA 22630 (540) 636-2509
Date Prepared
September 6, 1996
- Device Name: Brixton Infection Control Barrier
Classification Name: Dental Handpiece and Accessory FDA Classification: Class II per 21 CFR 872.4200
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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.
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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
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- Headrests
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- Air and Water Syringe sleeves (ties included)
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- Stools
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- X-Ray Heads
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- 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 Control Barriers support the finding of substantial equivalence.
§ 872.4200 Dental handpiece and accessories.
(a)
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.(b)
Classification. Class I.