Product Classification

• 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 Code: OAT
• 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: 872.3640
• 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

• 4-266 ISO 19023 First edition 2018-02
  Dentistry - Orthodontic anchor screws

Third Party Review

Not Third Party Eligible