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Sources: EU EUDAMED, US FDA
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Zimmer Dental Trabecular Metal, TMT4B10 IMP TM 4.1MM MTX FULL,10MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.(Catalog TMT indicates textured collar)
FDA Recall
Terminated
·Zimmer Inc.·Product code DZE·March 22, 2012
Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088
FDA Recall
Terminated
·The Straumann Company·Product code DZE·May 21, 2004
IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
FDA Recall
Terminated
·Zimmer Dental Inc·Product code DZE·January 6, 2016
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·August 8, 2016
SwishTapered Implant
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing, LLC·Product code DZE·December 12, 2016
BioHorizons 0.050 Hex Driver, Regular, REF 300-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007
RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560
FDA Recall
Terminated
·Straumann Manufacturing Inc·Product code DZE·June 6, 2005
NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices.
FDA Recall
Terminated
·Nobel Biocare USA LLC·Product code DZE·November 2, 2007
Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of the 2.2 mm pilot drill used in the site preparation for the placement of Straumann dental implants.
FDA Recall
Terminated
·Straumann Manufacturing Inc.·Product code DZE·May 28, 2008
Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043
FDA Recall
Terminated
·Straumann Manufacturing Inc.·Product code DZE·March 30, 2006
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
Zimmer Dental Trabecular Metal Implant, TMM4B11, 4.1mm x11.5 MM; 3.5 mm implant TM, MTX Rx, Sterile R, Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Catalog TMM indicates machined collar.
FDA Recall
Terminated
·Zimmer Inc.·Product code DZE·March 22, 2012
Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used
FDA Recall
Terminated
·Straumann USA, LLC·Product code DZE·September 24, 2014
IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13
FDA Recall
Terminated
·Zimmer Dental Inc·Product code DZE·July 10, 2017
Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
FDA Recall
Terminated
·Keystone Dental Inc·Product code DZE·August 25, 2017
Cover Screw, Headless Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
Certain Implant Straight Cover Screw Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
Implant Cover Screw Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
Certain Micromini Flat Implant Cover Screw Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015
O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZE·November 25, 2015