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U.S. Department of Health and Human Services

Product Classification

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Device implant, endosseous, root-form
Regulation Description Endosseous dental implant.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeDZE
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.3640
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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