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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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• Skyrock M is a paste/liquid system. • Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts. • It is moldable and non-sticky yet has an adhesive consistency. • Allows one to control consistency, wherever desirable, by adding more or less liquid. • Contains moderately hard filler for easier carving and shaping. • Does not require refrigeration: long shelf life at ambient temperatures. • Standard Skyrock M kit comes in two shades: one is contrasting, for easy distinguishing from tooth structure; the other is natural, for use under semi-transparent ceramics.
DENT ZAR, INC.
1015
In Commercial Distribution

  • D83610151 ()
1015

  • Dental composite resin
Acclaim is a highly polishable, self cure, paste/paste, Bis-GMA composite for anterior and posterior restorations. Material exhibits; high mechanical strength and excellent marginal adaptation. High filler content contributes to low shrinkage, low water sorption, low coefficient of thermal expansion and good wear and scratch resistance. Acclaim has a very good x-ray opacity, outstanding color stability and resistance to staining.
DENT ZAR, INC.
1012
In Commercial Distribution

  • D83610121 ()
1012

  • Dental composite resin
Saturn M-Light, Self & Dual-Cure Core Build-Up Material (1:4 Formula) • in dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light. • Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode. • Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts. • Moldable, non sticky consistency. • Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure. • Contains moderately hard filler for easier carving and shaping. • Does not require refrigeration: long shelf life at ambient temperatures. • The Standard Saturn M kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics.
DENT ZAR, INC.
1010
In Commercial Distribution

  • D83610101 ()
1010

  • Dental composite resin
• Eagle-Light, Self & Dual-Cure Core Build-Up Material In dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light. • Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode. • Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts. • Moldable, non-sticky consistency. • Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure. • Contains moderately hard filler for easier carving and shaping. • Does not require refrigeration: long shelf life at ambient temperatures. • The Standard Eagle kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics.
DENT ZAR, INC.
1009
In Commercial Distribution

  • D83610091 ()
1009

  • Dental composite resin
L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite) L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance. OUTSTANDING FEATURES OF THE MATERIAL High adhesive strength to etched enamel without the use of bonding agents. Superior aesthetics due to well balanced opacity and light reflectance. Excellent color stability. Reduced oxygen inhibited layer contributes to the ease of finishing. Does not require refrigeration. Shelf life in excess of two years. Fast in application–one component restorative system. Excellent flow of the material facilitates application. May be cured with any dentalcuring instrument operating in the visible range.
DENT ZAR, INC.
1008
In Commercial Distribution

  • D83610081 ()
1008

  • Dental composite resin
Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers. A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations.
DENT ZAR, INC.
1007
In Commercial Distribution

  • D83610071 ()
1007

  • Dental composite resin
Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers. A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations.
DENT ZAR, INC.
1006
In Commercial Distribution

  • D83610061 ()
1006

  • Dental composite resin
Atlas is used for: final cementation of implant prosthesis, crowns, bridges, in-lays, on-lays, Maryland bridges, veneers, cementation of posts and pins, pit and fissure sealants, periodontal splinting, and cementation of orthodontic bands and appliances.. OUTSTANDING FEATURES OF THE MATERIAL •Excellent handling characteristics •Dual-Cured •Fluoride release •X-ray opacity •Low irritation potential •Negligible solubility •Low film thickness •Excellent resistance to oral environment and mechanical strength assure good long-term performance •Long shelf life
DENT ZAR, INC.
0007
In Commercial Distribution

  • D83610050 ()
1007

  • Dental composite resin
Pearl is a self-cured, filled permanent cement designed for cementing conventional cast restorations on most vital and non-vital teeth. It also cements bonded bridges of both cast and etched (Maryland) and perforated base (Rochette) types. It is also suitable for cementing prefabricated laminate veneers, ceramic crowns, inlays, onlays, pins, posts and periodontal splinting. • Versatile. • Predictable, controllable and reproducible working time. • Excellent biological and chemical resistance to oral environment. • Excellent adhesion to both the tooth and metal surfaces. • High compressive and diametral tensile strength. • Simplicity in application.
DENT ZAR, INC.
1004
In Commercial Distribution

  • D83610041 ()
1004

  • Dental composite resin
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0065
In Commercial Distribution

  • D83600650 ()
0065

  • Dental composite resin
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