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510(k) Data Aggregation
K Number
K041098Device Name
COOL TEMP NATURAL
Manufacturer
Date Cleared
2004-05-13
(16 days)
Product Code
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
COLTENE AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Coltène Cool Temp Natural, in Vita® shades A1, A2 and A3.5, is indicated for temporary crown- and bridge restorations used for all techniques, i.e. with matrices or templates as well as Direct application in the dental laboratory.
Device Description
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K Number
K022224Device Name
COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
Manufacturer
Date Cleared
2002-09-18
(70 days)
Product Code
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
COLTENE AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For the cementation/affixing of metal and/or ceramic orthodontic brackets to teeth.
Device Description
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