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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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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.
0063
In Commercial Distribution

  • D83600630 ()
0063

  • 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.
0062
In Commercial Distribution

  • D83600620 ()
0062

  • 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 light-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.
0061
In Commercial Distribution

  • D83600610 ()
0061

  • Dental composite resin
• 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.
0060
In Commercial Distribution

  • D83600600 ()
0060

  • Dental composite resin
• 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.
0059
In Commercial Distribution

  • D83600590 ()
0059

  • Dental composite resin
• 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.
0058
In Commercial Distribution

  • D83600580 ()
0058

  • Dental composite resin
• Easy to apply; fast cure. • Outstanding depth of cure. • Reliable performance. • Good mechanical strength and wear resistance allows for an extended service time of up to six months. • Good biocompatibility shares the same basic chemistry with light cured cavity liners. • Easy removal. • Compatible with all known permanent restoratives and cements. • Long shelf life with no need for refrigeration. • Versatility in use; also suitable for making temporary inlays and onlays, endodontic stopping and emergency temporization.
DENT ZAR, INC.
0057
In Commercial Distribution

  • D83600570 ()
0057

  • 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.
0052
In Commercial Distribution

  • D83600520 ()
0052

  • 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.
0051
In Commercial Distribution

  • D83600510 ()
0051

  • 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.
0039
In Commercial Distribution

  • D83600390 ()
0039

  • Dental composite resin
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