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510(k) Data Aggregation
K Number
K963664Device Name
DENTAL HANDPIECE AND ACCESSORY
Manufacturer
Date Cleared
1996-10-24
(41 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
FILMTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
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,
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