BEUDAMED
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    Flow Tec Part Number 3786-754, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code EBF·October 22, 2010

    37% Etching Gel-1ml syringe 20 pk, part # T06A The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.

    FDA Recall
    Terminated ·Kerr/pentron Dba Kerr Corporation And Pentron Clinical·Product code EBF·March 31, 2011

    PREMISE, PART NO. 32653, 10 PACK UNIDOSE PREMISE A3.5, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.

    FDA Recall
    Terminated ·3M Company Health Care Business 3M Center·Product code EBF·June 15, 2015

    Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code DBF·November 21, 2018

    Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EBF·August 3, 2017

    Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EBF·August 3, 2017

    Artiste Flowable Value Pack Part Number N28VA, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code EBF·October 22, 2010

    37% Etching Gel-5ml syringe, part #N01IB The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.

    FDA Recall
    Terminated ·Kerr/pentron Dba Kerr Corporation And Pentron Clinical·Product code EBF·March 31, 2011

    The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather.

    FDA Recall
    Terminated ·Baro-Therapies, Inc·Product code CBF·August 8, 2014

    PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1m average particle size with narrow upper limit particle distribution.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code EBF·August 31, 2020

    SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A3, 20 - Dispensing tips, 29495. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes B1, 20 - Dispensing tips, 29499. Revolution is a flowable light cure hybrid resin restorative.

    FDA Recall
    Terminated ·Patterson Dental Supply, Inc.·Product code EBF·October 15, 2010

    Flow Tec Part Number 3784-514, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code EBF·October 22, 2010

    ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code DBF·October 9, 2012

    PREMISE, PART NO. 32658, 10 PACK UNIDOSE PREMISE B4, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.

    FDA Recall
    Completed ·RHONDIUM LIMITED·Product code EBF·January 31, 2019

    Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EBF·August 3, 2017

    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.

    FDA Recall
    Terminated ·Sechrist Industries Inc·Product code CBF·August 28, 2008

    PREMISE, PART NO. 32660, 10 PACK UNIDOSE PREMISE C2, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32662, 10 PACK UNIDOSE PREMISE C4, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008