Product Classification

• Device: varnish, cavity
• Regulation Description: Cavity varnish.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: LBH
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 872.3260
• 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

Recognized Consensus Standards

• 4-257 ISO 17730 First edition 2014-11-01
  Dentistry - Fluoride varnishes
• 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12
  Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• 4-280 ANSI ADA Standard No. 117-2018
  Fluoride varnishes
• 4-319 ISO 17730 Second edition 2020-09
  Dentistry - Fluoride varnishes

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