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510(k) Data Aggregation
K Number
K965032Device Name
THE PERIOSEAL DENTAL IMPLANT
Manufacturer
Date Cleared
1997-08-20
(246 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
PERIOSEAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indications for use: The PerioSeal® dental implant is intended to be surgically implanted into the edentulous areas of the mandible or maxilla to serve as support for a dental prosthesis. This device is intended for the treatment of edentulism in the totally or partially edentulous population, but limited to those individuals who are suitable candidates for the surgical and prosthetic procedures. The PerioSeal® dental implant is intended for use in the mandible or maxilla as an artificial root structure for replacement of a single tooth or as an abutment for retention of bridgework or dentures of various configurations. This device is intended for sale to or use on the order of a licensed dentist of physician.
Device Description
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