Product Classification

• Device: crown and bridge, temporary, resin
• Regulation Description: Temporary crown and bridge resin.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: EBG
• Submission Type: 510(k)
• Regulation Number: 872.3770
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ANSI ADA Specification No.80 2001 (Reaffirmed 2007) Dental Materials - Determination of Color Stability
• ANSI ADA Specification No.53 Polymer-Based Crowns and Bridge Resins:1999 (Reaffirmed 2008)
• ADA/ANSI
• ISO 10477 Second edition 2004-10-01 Dentistry - Polymer-based crown and bridge materials
• 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.