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510(k) Data Aggregation
K Number
K140202Device Name
TRAUSIM DENTAL IMPLANT SYSTEM
Manufacturer
Date Cleared
2014-12-12
(319 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
JIANGSU TRAUSIM MEDICAL INSTRUMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Trausim Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient The Trausim Dental Implants System's prosthetic components include abutment, healing cap and screw. The abutment is as dental implant systems essentially a connection part of dental implant and denture. The healing cap is used for covering the dental implant during healing period; the aim at avoiding soft tissue (gingival) get into the hole of dental implant, and shaping the gingival aesthetic form.
Device Description
The Trausim Dental Implants System's prosthetic components include abutment, healing cap and screw. The abutment is as dental implant systems essentially a connection part of dental implant and denture. The healing cap is used for covering the dental implant during healing period; the aim at avoiding soft tissue (gingival) get into the hole of dental implant, and shaping the gingival aesthetic form.
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