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U.S. Department of Health and Human Services

Product Classification

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Device dental stereotaxic instrument
Regulation Description Bone cutting instrument and accessories.
Definition To facilitate dental implant placement in patients that are partially endentulous or edentulous.
Physical State A cart mounted system that physically attaches to the patient as well as the surgical instrument in order to detect the location of the device in physical space.
Technical Method The device uses stereo cameras to detect tracking devices placed on both the surgical instrument as well as on the patient. The tracked image is then placed on a screen with predetermined anatomical landmarks to assist the clinician with the surgical placement.
Target Area Intraoral surgical procedures in the mouth.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodePLV
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.4120
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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