459 results
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37ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410. Custom temporary cover screws are for use in maintaining the soft tissue during the healing process of a dental restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NDA·December 11, 2006
Certain Low-Profile, Angled Abutment, Model Number ILPAC3217. Product is labeled in part: "***Biomet 3i***4555 Riverside Drive , Palm Beach Gardens, FL 33410 USA***REF ILPAC3217***LOT 2011091179***Certain Low Profile 17 Abutment***3.4mm(D) X 2mm(H)***Abutment:; Pillar; Abutment; Abutment; Pilastro; Pillar***CE dose***Use by 2016-09***Sterile using Radiation***RX Only***Do not reuse***Consult accompanying documents***Do not re-sterilize***Do not use if package is damaged***ILPAC3217***2011091179***"P-LBLNY3P***Rev. D***". Intended to provide a means to attach crown restorations or implant frameworks to implants.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·January 10, 2012
"***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF AC4425***Conical 25 ANGLED ABUTMENT***4.1mm(D) X 4mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1'***". Attach an implant to an implant restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·September 28, 2011
"***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF SWCA62***Conical Abutment Gold Standard ZR***6mm(D) X 2mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1'***". Attach an implant to an implant restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·September 28, 2011
***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
Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code LRO·July 22, 2013
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·June 25, 2014
"***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Made in USA*** Implant Innovations, Inc. Global Headquarters 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 342-5454 www.3i.online.com. Outside US 561-776-6700***Implant Innovations Siberica S.L., WTC Almeda Park, Ed. 1 Planta 1a Pl. De la Pau s/n 08940-Cornella de Llobregat (Barcelona) Spain. Phone: +34 934 705500. Fax +34 933 717 849. Lot Number: 602691.***" Biomet 3i healing abutments are temporary healing abutments for use in maintaining the soft tissue opening throughout the healing process of dental restoration.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NSQ·February 23, 2010
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·May 31, 2012
Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Certain Gingihue 15 degree Pre- Angled Post Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Conical EP Pick-Up Coping (Non-Hexed) Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Locator Abutment Impression Coping Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Certain Gingihue Post Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Gold -Tite Hexed Retaining Screw Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Certain Temporary Non-Hexed Cylinder Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Implant Twist Lock TM Coping Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
Certain Preformance 15 degrees Pre-Angled Post Dental implants
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·November 25, 2015
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·September 14, 2016