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U.S. Department of Health and Human Services

Product Classification

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Device handpiece, rotary bone cutting
Regulation Description Bone cutting instrument and accessories.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeKMW
Premarket Review Dental Devices (DHT1B)
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
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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