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510(k) Data Aggregation
K Number
K170873Device Name
Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl
Manufacturer
Date Cleared
2017-10-02
(193 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
SwissMediTec GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- 1) Direct anterior and posterior restorations (including occlusal surfaces)
- 2) Direct veneers
- 3) Correction of tooth position and tooth shape
- 4) Indirect restorations including inlays, onlays and veneers
- 5) Intraoral repairs of fractured restorations
- 6) Core build-ups
- 7) Splinting
Device Description
The subject devices (Medi galaxy Flow, Medi Classic, Medi Jupiter,Medi Opaque Plus, Medi Opaque Posterior.Medi White Pearl) are visible light-cure, radiopaque restorative material (Composite) with high polishingability, excellent physical properties and are designed for anterior and posterior restorations. The subject devices formulated from multifunctional methacrylate monomer-based resin, photo initiator, silanated inorganic filler and pigments. Available in multiple shades. These restoratives provides high strength and low wear for durability. They are packaged in traditional syringes and Pre-Loaded Tips.
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