Product Classification

• Device: crown and bridge, long-term temporary, resin
• Regulation Description: Temporary crown and bridge resin.
• Definition: For the fabrication of long-term temporary crowns and bridges
• Physical State: Polymeric, may include ceramic filler
• Technical Method: Achieves its intended function by providing a patient-matched crown or bridge that is cemented onto a patient's dentition to restore normal mastication
• Target Area: oral cavity
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: POW
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 872.3770
• 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 Standard

• 4-295 ADA ANSI Standard No. 41-2020
  Evaluation of Biocompatibility of Medical Devices Used in Dentistry

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