Product Classification

• Device: resin, denture, relining, repairing, rebasing
• Regulation Description: Denture relining, repairing, or rebasing resin.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: EBI
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 872.3760
• 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

• 4-130 ANSI ADA Standard No. 17-1983 (R2014)
  Denture Base Temporary Relining Resins
• 4-232 ISO 20795-1 Second edition 2013-03-01
  Dentistry - Base polymers - Part 1: Denture base polymers
• 4-233 ISO 20795-2 Second edition 2013-03-01
  Dentistry - Base polymers - Part 2: Orthodontic base polymers
• 4-240 ISO 21563 First edition 2013-08-15
  Dentistry - Hydrocolloid impression materials
• 4-241 ISO 7491 Second edition 2000-09-01
  Dental materials - Determination of colour stability
• 4-242 ISO 10139-1 Third edition 2018-03
  Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
• 4-258 ISO 10139-2 Third edition 2016-06-15
  Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
• 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12
  Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• 4-294 ADA ANSI Standard No. 139-2020
  Dental Base Polymers
• 4-295 ADA ANSI Standard No. 41-2020
  Evaluation of Biocompatibility of Medical Devices Used in Dentistry
• 4-301 ISO 21563 Second edition 2021-08
  Dentistry - Hydrocolloid impression materials

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