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510(k) Data Aggregation
K Number
K140512Device Name
UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE
Manufacturer
Date Cleared
2014-07-02
(124 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
JUNO DENTISTRY LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UFill Bulk Fill Posterior Flowable Composite is indicated for use (i) in fillings with layer thicknesses up to 4mm in Class I and II cavities, (ii) in cavity lining- as a first (bottom layer) in Class I and II cavities.
Device Description
UFill Bulk Fill Posterior Flowable Composite is a light cure radiopaque posterior composite for use in the Bulk-Fill Technique. The flowable viscous material is suitable for filling layers of up to 4mm in thickness and as a cavity lining (bottom layer) for both Class I and II restorations. Placed in a unit dose needle capsule containing 0.25g of material, the device is delivered by a standard dental unit-dose tip applicator dispenser gun, and offered in a universal dentin shade that is formulated and manufactured without Bis-GMA, HEMA, or TEG-DMA.
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