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U.S. Department of Health and Human Services

Product Classification
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Device dental navigation system
Regulation Description Bone cutting instrument and accessories.
Definition Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures.
Physical State The dental navigation system is comprised of navigation software, user interface, patient tracker, dental instrument tracker, display screen and accessories.
Technical Method The navigation system software receives in real-time the position of a dental instrument and the patient which is displayed on a screen.
Target Area Intraoral for general dentistry procedures
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeQRY
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 872.4120
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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