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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device portable dental operative unit
Regulation Description Dental operative unit and accessories.
Definition A portable dental operative unit is a device intended to serve as a base station for dental instruments and accessories, delivering utilities such as compressed air, water, suction, and power to handheld dental instruments. The device is designed for use in non-permanent healthcare environments, including dental clinics, hospitals, mobile clinics, long-term care facilities, patient residences, schools, correctional facilities, military or humanitarian field settings, and similar settings, by dental professionals.
Product CodeSJH
Regulation Number 872.6640
Device Class 1


Premarket Reviews
ManufacturerDecision
LAKONG MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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