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U.S. Department of Health and Human Services

Product Classification

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Device crown and bridge, long-term temporary, 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 CodePOW
Premarket Review Division of Dental and ENT Devices (DHT1B)
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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons