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U.S. Department of Health and Human Services

Product Classification

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Device scaler, ultrasonic
Regulation Description Ultrasonic scaler.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeELC
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.4850
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
Third Party Review
Accredited Persons
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