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U.S. Department of Health and Human Services

Product Classification

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Device system, dental, hydrokinetic, caries removal & cavity preparation
Regulation Description Bone cutting instrument and accessories.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeMXF
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental 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
Third Party Review
Accredited Persons
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