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U.S. Department of Health and Human Services

Product Classification
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Device implant, endosseous, orthodontic
Regulation Description Endosseous dental implant.
Definition It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
Physical State Generally fabricated from titanium or titanium alloy in a screw form or screw and plate combination.
Technical Method It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices.
Target Area Maxilla and mandibular jaw bone.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeOAT
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT 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
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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