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510(k) Data Aggregation
K Number
K213749Device Name
G7, Dental Operative Unit and Accessories
Manufacturer
Date Cleared
2023-04-03
(489 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
Shinhung Company Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The G7 Dental System and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
Device Description
The G7 dental chair with operative unit is a dental chair with an operative unit attached for patient to sit during the dental diagnosis, treatment and /or operation. The dental chair has adjustable headrest, backrest, seat height and armrests. The proposed device also consists of dentist table with instrument holders, assistant table, water unit, arm system, cuspidor (spittoon), dental light and foot control. The instrument holder includes a 3-way syringe and salvia ejector supplied by DCI which are cleared by FDA (K151987).
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K Number
K151996Device Name
TAURUS C1
Manufacturer
Date Cleared
2016-01-22
(186 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
SHINHUNG COMPANY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TAURUS C1 Dental System and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
Device Description
TAURAUS C1 is a dental chair and units to be used to take for diagnosis and therapy of patients. It consists of the main unit and accessories.
The dental chair is used for patient to sit during the dental diagnosis, treatment and /or operation. The dental unit consists of patient chair, dentist table with instrument holders, assistant table, water unit, arm system, cuspidor (spittoon) and dental light. The dental unit system is used by trained dentists and /or dental assistants to supply air, water, vacuum and electrical power to dental devices and accessories to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
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