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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 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

    3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.

    FDA Recall
    Open, Classified ·3M Unitek Corporation·Product code KLE·November 26, 2024

    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

    Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.

    FDA Recall
    Completed ·Ultradent Products, Inc.·Product code KLE·June 1, 2022

    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