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U.S. Department of Health and Human Services

Product Classification

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Device chair, dental, with operative unit
Regulation Description Dental chair and accessories.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeKLC
Premarket Review Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.6250
Device Class 1
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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