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510(k) Data Aggregation
K Number
K992582Device Name
PACIFIC IMPLANT TITANIUM ENDODONTIC POINT
Manufacturer
Date Cleared
1999-10-21
(80 days)
Product Code
Regulation Number
872.3840Why did this record match?
Product Code :
EKL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pacific Implant Titanium Endodontic Point is intended for use during endodontic therapy to fill permanently the root canal of a tooth.
Device Description
The product is a titanium endodontic point having the same intended use as endodontic silver points; i.e. to be used during endodontic therapy to fill permanently the root canal of a tooth. The device is fabricated in various endodontic point sizes of titanium CP meeting the ASTM F 67 standard specification for unalloyed titanium for surgical implant applications.
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K Number
K961089Device Name
PULPDENT ENDOPREP II
Manufacturer
Date Cleared
1996-04-23
(35 days)
Product Code
Regulation Number
872.3840Why did this record match?
Product Code :
EKL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PULPDENT Endo-Prep II is a 17 % EDT A chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin.
Device Description
PULPDENT Endo-Prep II is a 17 % EDT A chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin. PULPDENT Endo-Prep II will be offered in two viscosities, thin and thick, so that the dentist can apply the product either directly to the canal ovening or to the file.
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