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510(k) Data Aggregation
K Number
K243951Device Name
TEMP MASTER, PMMA-based dental resin
Manufacturer
Taiwan Dental Materials CO., LTD.
Date Cleared
2025-02-21
(60 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
Taiwan Dental Materials CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TEMP MASTER, PMMA-based dental resin developed by Taiwan Dental Materials CO., LTD. is a self-cured resin indicated for the fabrication of short-term restorations including temporary inlays, crowns, and bridges, which can protect or restore damaged teeth while permanent restorations are being prepared. It is a traditional auto-cured PMMA-based resin composed of powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature.
Device Description
TEMP MASTER, PMMA-based dental resin, is a self-curing (cold-cure) material designed to fabricate temporary crowns and bridges. It consists of two components: powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature. Classified as a Type 1 (autopolymerizable) acrylic resin according to ISO 10477 standards, TEMP MASTER, PMMA-based dental resin provides reliable performance for temporary restorations.
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