7 results
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49ms
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Sources: EU EUDAMED, US FDA
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Enforcement
Class II
·Terminated·Zest Anchors LLC·February 12, 2014
LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Recall
Terminated
·Zest Anchors LLC·Product code DZE·January 16, 2014
IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
FDA Recall
Terminated
·CMP Industries, Llc·Product code EBI·April 28, 2016
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.
FDA Recall
Terminated
·CMP Industries, Llc·Product code EBI·April 28, 2016
***REF INT411***OSSEOTITE Tapered Certain Implant 4 x 11.5mm***Sterile Using Radiation***Rx Only***BIOMET 3i Dental lberica S.L.WTC Almeda Park, Ed, 1 Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain***Phone +34 934-705-500; Fax +34 933-717-849. Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code O-FY·March 10, 2011