← Product Code [EFB](/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB) · K963664 # DENTAL HANDPIECE AND ACCESSORY (K963664) _Filmtech, Inc. · EFB · Oct 24, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K963664 ## Device Facts - **Applicant:** Filmtech, Inc. - **Product Code:** [EFB](/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB.md) - **Decision Date:** Oct 24, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4200 - **Device Class:** Class 1 - **Review Panel:** Dental ## 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. ## Regulatory 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](/device/K900093.md)) - Barrier All Film ([K952234](/device/K952234.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 (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 ## 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* 18 {1} * 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. 19 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K963664](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K963664) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com