Product Classification

• Device: dental barriers and sleeves
• Regulation Description: Surgical drape and drape accessories.
• Definition: Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
• Physical State: Clear polymer film
• Technical Method: Adhesively applied to patient contacting surfaces of reusable dental instruments/devices.
• Target Area: For devices to be used in dental surgery.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: Dental
• Product Code: PEM
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 878.4370
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc