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510(k) Data Aggregation
K Number
K242611Device Name
Integral Dental Units
Manufacturer
Mipont Medical Equipment Co., Ltd.
Date Cleared
2025-05-27
(266 days)
Product Code
EIA
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
Mipont Medical Equipment Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dental Unit is intended to supply power to and serve as a base for dental devices, and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
Device Description
The Integral dental unit is a dental treatment unit tested in accordance with IEC 80601-2-60. This product is used in dentistry only and may only be used by trained medical personnel and trained professionals in the field of general dentistry. The Integral dental unit consists of a dental chair, side box, dental light, instrument tray, 3-way syringe, strong suction, weak suction, cuspidor, x-ray film viewer, and the wired foot pedal. Optional accessories include ultrasonic scalers, curing lights, dental handpieces and dental electrical motor, which are to be purchased by the user. The dental operative unit is equipped with a dental light and water heater. The dental operative unit mainly relies on electricity, compressed air, water to achieve all functions. Various ancillary dental devices can be connected to the Integral dental unit which are attached by means of industry standard ISO connections. The ancillary dental devices include 3-way syringe, strong suction and weak suction vacuum instruments are manufactured by the Mipont Medical Equipment Co., Ltd. None of the Integral dental unit parts or accessories are provided sterile.
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