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
• Submission Type: 510(k)
• Regulation Number: 872.3760
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 10139-2 Second edition 2009-08-01 Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
• ISO 10139-1:2005 Technical Corrigendum 1 2006-03-01 Dentistry - Soft lining materials for removable dentures - part 1; Materials for short-term use
• ANSI ADA Specification No.80 2001 (Reaffirmed 2007) Dental Materials - Determination of Color Stability
• ADA/ANSI Specification No. 12: 2002 (Reaffirmed 2008) Denture Base Polymers
• ADA/ANSI Specification No.75 - Resilient Lining Materials for Removable Dentures, Part 1: Short-Term Materials: 1997 (Reaffirmed 2003)
• ADA Specification No.17 - Denture Base Temporary Relining Resins: 1983 (Reaffirmed 2006)
• ISO 10139-1 Second edition 2005-02-15 Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
• ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.