Search Results
Found 1 results
510(k) Data Aggregation
K Number
K152652Device Name
PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement
Manufacturer
Date Cleared
2016-04-05
(202 days)
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
GAIA DENTAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PackFil RMGI Restorative Cement is indicated for filling and restoration of tooth of following typical applications:
- Primary teeth restorations;
- Class I restorations:
- Class III and V restorations:
- Transitional restorations;
- Base liners or laminated/sandwich restorations;
- Selective core build-ups (>50% coronal tooth intact);
Device Description
PackFil Resin Modified Glass Ionomer (RMGI) Restorative Cement is used by dental professionals and intended for filling and restoration of teeth. The subject device possesses triple curing mechanisms of conventional acid-base glass ionomer reaction. methacrylate resin chemical curing and light curable on demand. It is a tooth colored, radiopaque (equivalent of 2.5 mm of aluminum), two-part paste/paste resin modified glass ionomer restorative cement material, with each part is packaged separately when not in use. PackFil RMGI provides the common benefits typical of conventional glass ionomer materials, with the feature of being packable after the two parts mixed together. The filler content of this system is primarily a combination of traditional silane treated barium-boro-silicate glass filler and radiopaque acid reactive fluoroaluminosilicate glass filler having a hybrid particle size range from about 0.01 up to about 5 micrometers while the resin system has a combination of aqueous polyacrylic acid copolymer, phosphate and other polymerizable methacrylate resins.
Ask a Question
Ask a specific question about this device
Page 1 of 1