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U.S. Department of Health and Human Services

Product Classification

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Device blade-form endosseous dental implant
Regulation Description Endosseous dental implant.
Definition Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNRQ
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.3640
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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