Product Classification

• 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 Code: PLV
• 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 Standards

• 4-244 ISO 8325 Second edition 2004-09-15
  Dentistry - Test methods for rotary instruments
• 4-317 ISO 8325 Third edition 2023-03
  Dentistry - Test methods for rotary instruments

Third Party Review

Not Third Party Eligible