DENT ZAR, INC.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• SELF CURE BONDING AGENT

  1996-07-03

  DENT ZAR, INC.

• SUPERIOR PHOTOCURING HYBRID COMPOSITE

  1996-04-26

  DENT ZAR, INC.

• ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE

  1996-04-26

  DENT ZAR, INC.

• ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE

  1996-04-26

  DENT ZAR, INC.

• LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS

  1996-04-26

  DENT ZAR, INC.

• LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS

  1996-04-26

  DENT ZAR, INC.

• FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS

  1996-04-26

  DENT ZAR, INC.

• ENAMEL CONDITIONER (ENAMEL ETCHING AGENT)

  1996-04-26

  DENT ZAR, INC.

• CONCORD MARYLAND BRIDGE CEMENT

  1996-04-26

  DENT ZAR, INC.

• ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE

  1996-03-22

  DENT ZAR, INC.

• SKYROCK AND LIGHT SUPERBOND

  1989-10-20

  DENT ZAR, INC.

• ZAROLAN, DUALAN, TITAN AND SUPERON

  1989-06-09

  DENT ZAR, INC.

GUDID#

• Dental Etchant (Enamel Conditioner), 12g Syringe - Etch Gel 12 g Syringe with disposable tips, also, available for bulk purchase-1 kg bottle. Dent Zar’s etch gel is a 37% phosphoric acid solution. • Convenient dispensing system with disposable tips• Easy to wash off• Economical• Colored for precise application• Excellent wetting characteristics• Non-drying• Direct to tooth application with disposable luer-lock tips• Refillable applicator syringes

  DENT ZAR, INC.

  2016-09-04

• Dental Etchant (Enamel Conditioner), 1kg Bottle - Etch Gel-available for bulk purchase-1 kg bottle. Dent Zar’s etch gel is a 37% phosphoric acid solution. • Convenient dispensing system with disposable tips• Easy to wash off• Economical• Colored for precise application• Excellent wetting characteristics• Non-drying• Direct to tooth application with disposable luer-lock tips• Refillable applicator syringes

  DENT ZAR, INC.

  2016-09-04

• Z Bond-Visible Light Cure One-Step Bonding Adhesive - Dent Zar’s Z-Bond is a One-Step Light-Cured Self-Etching Dentin/Enamel Bonding Adhesive, which releases fluorides and does not require mixing, because the adhesive combines properties of etching and bonding in a single bottle. The result is fast and saves chair time. Z-Bond markedly reduces sensitivity due to the fact that the adhesive penetrates the smear layer and adheres to the tooth structure without opening tubules. The work effort is significantly reduced and simplified with Z Bond. All adhesive treatment steps are included in one component. Z Bond is a 7th generation of bonding dentin/enamel adhesives. Z Bond is designed to promote adhesion to tooth structure in the following applications:

  DENT ZAR, INC.

  2016-09-03

• Bonding Agent Visible Light Cure - • Simple and fast application technique• Compatible with all light-cured restorative materials and cements• Long shelf-life with no need for refrigeration• Economical• No pulp irritation

  DENT ZAR, INC.

  2016-09-03

• Bonding Agent (Self-Cure) Part A & Part B - • Simple and fast application technique.• Compatible with all light-cured, and self-cured restorative materials and cements.• Long shelf-life with no need for refrigeration.• Economical.• No pulp irritation.

  DENT ZAR, INC.

  2016-09-03

• Polishers - A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

  DENT ZAR, INC.

  2022-03-08

• LED Curing Light - A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.

  DENT ZAR, INC.

  2022-03-07

• Dental Diamond Burs - Dental burs are a vital tool required for almost every dental treatment and procedure. They are necessary for cutting, grinding, and removing hard and soft tissue and are designed to attach to the rotary dental handpiece for fast and efficient dental work.

  DENT ZAR, INC.

  2022-03-07

• Acorn Nano Micro Hybrid-Syringe Shade A1 - 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.

  2016-09-02

• Acorn Nano Micro Hybrid-Syringe Shade A2 - 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.

  2016-09-02

• Acorn Nano Micro Hybrid-Syringe Shade A3 - 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.

  2016-09-02

• Acorn Nano Micro Hybrid-Syringe Shade B2 - 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.

  2016-09-02

• Acorn Nano Micro Hybrid-Syringe Shade A4 - 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.

  2016-09-02

• Acorn Nano Micro Hybrid-Syringe Shade B3 - 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.

  2016-09-02

• Acorn Nano Micro Hybrid-Syringe Shade C2 - 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.

  2016-09-02

• Acorn Nano Micro Hybrid-Syringe Shade D3 - 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.

  2016-09-02

• Acorn Nano Micro Hybrid-Syringe Shade A3.5 - 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.

  2016-09-02

• Acorn Nano Micro Hybrid-Syringe Shade C3 - 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.

  2016-09-02

• Acorn Nano Micro Hybrid-Syringe Shade B1 - 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.

  2016-09-02

• Acorn Nano Micro Hybrid-Syringe Incisal - 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.

  2016-09-02

• Acorn Single Dose Caps. Sh. A1 - 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.

  2016-09-02

• Acorn Single Dose Caps. Sh. A2 - 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.

  2016-09-02

• Acorn Single Dose Caps. Sh. A3 - 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.

  2016-09-02

• Acorn Single Dose Caps. Sh. B2 - 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.

  2016-09-02

• Acorn Single Dose Caps. Sh. A4 - 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.

  2016-09-02

• Acorn Single Dose Caps. Sh. B3 - 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.

  2016-09-02

• Acorn Single Dose Caps. Sh. C2 - 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.

  2016-09-02

• Acorn Single Dose Caps. Sh.D3 - 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.

  2016-09-02

• Acorn Single Dose Caps. Sh.A3.5 - 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.

  2016-09-02

• Acorn Single Dose Caps. Sh. C3 - 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.

  2016-09-02

• Acorn Single Dose Caps. Sh. B1 - 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.

  2016-09-02

• Acorn Single Dose Caps. Incisal - 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.

  2016-09-02

• Olympian M Temporary Cement Auto-Mix System Single Carthridge - Olympian M is used for cementating temporary crowns and splints. Retention of temporary crowns, sealing dressing in teeth during root canal therapy procedures.Trial cementation of permanent restorations prior to final insertion.Testing of interproximal contacts prior to final placement.

  DENT ZAR, INC.

  2016-09-02

• Olympian-M Temporary Cement, Syringe Part A - Olympian M is used for cementating temporary crowns and splints. Retention of temporary crowns, sealing dressing in teeth during root canal therapy procedures.Trial cementation of permanent restorations prior to final insertion.Testing of interproximal contacts prior to final placement.

  DENT ZAR, INC.

  2016-09-02

• Olympian-M Temporary Cement, Syringe Part B - Olympian M is used for cementating temporary crowns and splints. Retention of temporary crowns, sealing dressing in teeth during root canal therapy procedures.Trial cementation of permanent restorations prior to final insertion.Testing of interproximal contacts prior to final placement.

  DENT ZAR, INC.

  2016-09-02

• Pearl Composite Luting Cement Auto-Mix System, Single Carthridge - 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.• Auto-mix system.• 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.

  2016-09-03

• Pearl Composite Luting Cement Syringe System, Part A Single Syringe - 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.

  2016-09-03

• Pearl Composite Luting Cement Syringe System, Part B Single Syringe - 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.

  2016-09-03

• L-SHA-Flowable Composite Syr. Shade A1 - 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.

  2016-09-02

• L-SHA-Flowable Composite Syr. Shade A2 - 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.

  2016-09-02

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