97 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Cardio Vascular-Allura Centron, system code 722400
FDA Recall
Terminated
·Philips North America, LLC·Product code OWB·December 30, 2019
Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.
FDA Enforcement
Class II
·Terminated·Philips Healthcare·August 1, 2018
Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC. Product Usage: The intended use of this device is as a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include self-etch base liner, restorations of carious lesions, Class I, III and V cavity preparations and pitt and fissure sealant.
FDA Recall
Terminated
·Kerr Corporation·Product code EBF·August 19, 2010
Brand Name: TempSpan CMT Temporary Cement, a temporary cement. Part Number: N69CA. The intended use of this device is to affix a temporary dental devices such as crowns or bridges to a tooth.
FDA Recall
Terminated
·Kerr Corporation·Product code EMA·March 3, 2011
Cardio Vascular-Allura Centron, system code 722400
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28VA A1 N28B N28VB A2 N28C N28VC A3 N28D N28VD A3.5 N28E N28VE A4 N28F N28VF B1 N28G N28VG B2 N28J N28VJ C1 N28K N28VK C2 N28L N28VL C3 N28N N28VP D2 N28R N28VR Universal Opaque N28XA N28VXA A0 N28XC N28VXC Incisal. The intended use of this 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 Artiste 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·March 3, 2011
Flow Tec Nano-Hybrid Flowable Affected Product Syringe Part No. Value Pack Part. No. Shade BEN3784-514 BEN3786-754 A1 BEN3784-532 BEN3786-763 A2 BEN3784-541 BEN3784-738 A3 BEN3784-550 BEN3784-747 A3.5 BEN3784-569 BEN3784-756 A4 BEN3784-578 BEN3784-765 B1 BEN3784-596 BEN3784-774 B2 BEN3784-603 BEN3784-783 C1 BEN3784-612 BEN3784-792 C2 BEN3784-621 BEN3784-809 C3 BEN3784-649 BEN3784-818 D2 BEN3784-722 BEN3784-818 Universal Opaque BEN3784-685 BEN3784-827 A0 BEN3784-701 BEN3784-836 Incisal. The intended use of this 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 Artiste 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·March 3, 2011
37% Etching Gel-3ml syringe, part #N01H 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
37% Etching Gel-1ml syringe 50 pk, part # T06B 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
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
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
Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
FDA Recall
Terminated
·Kerr/pentron Dba Kerr Corporation And Pentron Clinical·Product code EMA·July 8, 2011
37% Etching Gel-1ml syringe, part # T06 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
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
Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural Elegance (private label of Cement-It) are indicated as a luting cement bonding system for porcelain crowns, inlays, and onlays and other dental restorations, including ceramics, metal alloys and composite restoratives.
FDA Recall
Terminated
·Kerr/pentron Dba Kerr Corporation And Pentron Clinical·Product code EMA·March 17, 2011
Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material.
FDA Recall
Terminated
·Sybron Dental Specialties·Product code ELW·November 4, 2010
Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.) with probable internal diseases or injuries for: " Dedicated vascular and carotid imaging applications, including diagnostic and interventional procedures. " Cardiac imaging applications including diagnostics, interventional rocedures, pacemaker implantations and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·February 10, 2016
Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates.
FDA Recall
Terminated
·Kerr Corporation·Product code EMA·March 3, 2011
TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
FDA Recall
Terminated
·Jeneric/Pentron·Product code EBG·October 22, 2009
Artiste Flowable Part Number N28A, 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