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510(k) Data Aggregation
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Applicant Name (Manufacturer) :
MEDISCITEC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The M root-form endosseous dental implant fixture is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore the patient's chewing function. The M endosseous dental implant abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. The M root-form endosseous dental implant is not intended for immediate loading.
Device Description
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K Number
K072447Device Name
PENTABORN
Manufacturer
Date Cleared
2008-02-15
(168 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
MEDISCITEC INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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