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510(k) Data Aggregation
K Number
K082591Device Name
FLEXITIME BITE
Manufacturer
HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION
Date Cleared
2008-12-05
(88 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used for standards bite registrations in the end bite position Coating of bite forks Key material for needle point registration Production of small model segments.
Device Description
The product is developed under the project name D 922. Flexitime bite is a scannable polyvinyl siloxane for bite registration with superior hardness and a very short application time in mouth. Its surface properties and optimised colour enable it to be optically recorded in CAD/CAM systems to portray the antagonists. Flexitime Bite can be scanned in the Heraeus scanner and many other CAD/CAM systems.
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