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    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.

    FDA Enforcement
    Class II ·Terminated·Ultradent Products, Inc.·June 27, 2012

    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code KLE·May 24, 2012

    Tooth bonding resin. Optibond Solo Plus Bottle Kit, Part Number 31514, Lot Number 429106

    FDA Recall
    Terminated ·Kerr Corp·Product code KLE·March 3, 2006

    Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.

    FDA Recall
    Terminated ·Novocol, Inc.·Product code KLE·July 16, 2014

    Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.

    FDA Recall
    Terminated ·Heraeus Kulzer Inc., Dental Products Division·Product code KLE·July 9, 2007

    Tooth bonding resin. Premise Starter Unidose Kit, Part Number 32684, Lot Numbers 427915

    FDA Recall
    Terminated ·Kerr Corp·Product code KLE·March 3, 2006

    Tooth bonding resin. Nexus 2 Starter Kit, Part Number 31955, Lot Numbers 428570 & 429640

    FDA Recall
    Terminated ·Kerr Corp·Product code KLE·March 3, 2006

    Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code KLE·August 24, 2009

    Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item Description N01I Bond-1 Prim/Adhesive Kit N01IAA Bond-1 Primer/Adhesive 4ml N01IAB Bond-1 Primer/Adhesive 6ml N04 Lute-it w/ Bond-1 kit N04B Lute-t w/Bond-1 Intro Kit N31B Bond-1 C&B Prim/Adhesive N33 Cement-it Universal C&B Resin. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

    FDA Recall
    Terminated ·Kerr Corporation·Product code KLE·May 27, 2010

    OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966

    FDA Recall
    Terminated ·Kerr Corp·Product code KLE·August 29, 2006

    Tooth bonding resin. Premise Master Unidose Kit, Part Number 32612, Lot Numbers 428576

    FDA Recall
    Terminated ·Kerr Corp·Product code KLE·March 3, 2006

    VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied with phosphoric acid etching (selective enamel etching or total-etch) of the dental hard tissue as well as without (self-etch). A1] Adhesive for direct restorations of all classes of cavities using light-curing composite /compomer / Ormocer materials with a methacrylate base. [A2] Adhesive for core build-ups made of light-curing composite materials. [A3] Adhesive for indirect restorations with light-curing luting composites. [B] Intraoral repair of composite, compomer or Ormocer restorations, ceramic veneers and allceramic restorations without an additional primer. [C] Treatment of hypersensitive tooth necks. [D] Protective varnish for glass ionomer cement restorations. [E1] Sealing of cavities prior to amalgam restorations. [E2] Sealing of cavities and core preparations prior to the temporary luting of indirect restorations. In combination with Futurabond M+ DCA (Dual Cure Activator): [F1] Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups.

    FDA Recall
    Terminated ·Voco GmbH Anton-Flettner-Strasse 1-3 Cuxhaven Germany·Product code KLE·November 3, 2016

    Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.

    FDA Recall
    Terminated ·Novocol, Inc.·Product code KLE·July 16, 2014

    Tooth bonding resin. Optibond Solo Plus Dual Cure Kit, Part Number 31736, Lot Number 427793

    FDA Recall
    Terminated ·Kerr Corp·Product code KLE·March 3, 2006

    Tooth bonding resin. Optibond Solo Plus, Part Number 31513, Lot Numbers 427936, 428569, & 428290

    FDA Recall
    Terminated ·Kerr Corp·Product code KLE·March 3, 2006

    Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

    FDA Recall
    Terminated ·Heraeus Kulzer Inc., Dental Products Division·Product code KLE·July 9, 2007

    Tooth bonding resin. Nexus 2 Kit, Part Number 31954, Lot Number 428572

    FDA Recall
    Terminated ·Kerr Corp·Product code KLE·March 3, 2006

    Tooth bonding resin. Premise Master Syringe Kit, Part Number 32611, Lot Numbers 428730

    FDA Recall
    Terminated ·Kerr Corp·Product code KLE·March 3, 2006

    Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.

    FDA Recall
    Terminated ·Cosmedent, Inc.·Product code KLE·September 28, 2017

    Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, A1 c) in whole blood. The separation is based on the principles of high performance liquid chromatography. Technology Overview: The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-1 0 incorporates the use of a dedicated software system for instrument control, data collection and analysis. The D-10 Software performs reduction of raw data collected from each analysis. Reagent Kit Information: The D-10 Hemoglobin A1c Program utilizes principles of ion-exchange High-performance liquid chromatography (HPLC). The D-10 Hemoglobin Ale Program is based on chromatographic separation of HbA1c on a cation exchange cartridge. The Bio-Rad D-10 Hemoglobin Ale Program is intended for the percent determination of hemoglobin A1 c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad D-10 Hemoglobin A1c Program is intended for Professional Use Only. The D-10 Hemoglobin A1c Program is for use only with the Bio-Rad D-10 Hemoglobin Testing System.

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc., Hercules, CA 4000 Alfred Nobel Dr Hercules CA 94547-1803·Product code LCP·September 8, 2010