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510(k) Data Aggregation
K Number
K992001Device Name
TRAY-LINK
Manufacturer
Date Cleared
1999-11-02
(140 days)
Product Code
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
SILICON-UND COMPOSITE SPEZIALITATEN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Super adhesive system for adhering A-silicone and C-silicone impression materials on disposable plastic or light cured custom trays.
Device Description
It is the intention of S & C Polymer GmbH to manufacture the TRAY-LINK cited above which can be used as adhesive system for adhering silicone impression materials on disposable plastic or light cured custom trays.
The cited TRAY-LINK material S & C Polymer GmbH manufactures for Pharmex and Henry Schein contains a chemistry commonly found in current dental materials.
The purpose of this material for use by the dentist or technician is to build a chemical link between impression materials and the impression trays.
The chemical compositions of the key components A-LINK of the TRAY-LINK system are substantially equivalent to the denture priming component A-Soft Prime of the product A-Soft Reline 510(k) K984483.
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K Number
K991450Device Name
ETCHING GEL
Manufacturer
Date Cleared
1999-07-09
(74 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
SILICON-UND COMPOSITE SPEZIALITATEN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For etching dentin and enamel.
Device Description
Not Found
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K Number
K960938Device Name
PROV-KB
Manufacturer
Date Cleared
1996-04-18
(41 days)
Product Code
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
SILICON-UND COMPOSITE SPEZIALITATEN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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