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510(k) Data Aggregation
K Number
K231845Device Name
Dental unit Model: Mare
Manufacturer
Foshan Safety Medical Equipment Co., Ltd
Date Cleared
2024-02-28
(251 days)
Product Code
EIA
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
Foshan Safety 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 Dental Unit(model: Mare) 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 professional in the field of general dentistry. Dental Unit (model: Mare) consists of dental chair, arm dentist unit, assistant's unit, dental light, cuspidor, water unit, and multi-function foot control. It mainly relies on electricity, compressed air, water to achieve all functions. Various ancillary dental devices can be connected to the Dental Unit (model: Mare) which are attached by means of industry standard ISO connections. The ancillary dental devices include pneumatic handpieces, 3-way syringe, strong suction and weak suction vacuum instruments. The ancillary dental devices include 3-way syringe, strong suction and weak suction vacuum instruments are 510k clarence in the K142206. Based on Safety does not manufacture pneumatic handpieces, the pneumatic handpieces shall be purchased by the enduser. The recommended pneumatic handpieces are 510(k) clearance K170229 and K170236, which are held by GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. None of the Dental Unit (model: Mare), parts or accessories are provided sterile.
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