18 results
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62ms
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Sources: EU EUDAMED, US FDA
TWIST DRILL (DISPOSABLE) 2.75MM X 15MM
FDA Adverse Event
Malfunction
·BIOMET 3I, INC.·Product code ERL·May 23, 2007
"***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 800-342-5454 www.biomet3i.com Please consult instructions for use and recommendation***For Dental Lab use ONLY Non-sterile/For single Use***" Indicated for use in restorative procedure to affix the final prosthesis to the abutment. Coping and frameworks provide the base structure for final porcelain application as the final step of creating a restoration. The devices are intended to be used to create final restoration for dental reconstruction with either a prepared tooth or dental implant abutment.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NSP·December 1, 2010
Biomet 3i Dental Iberica S.L.U
Authorized representative
🇪🇸 Spain·2 Manufacturers·628 Devices
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
"***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
Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.
FDA Recall
Terminated
·Biomet 3i, Inc.·Product code EJB·May 9, 2008
BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X 2mm(H), BioMet 3i, Palm Gardens, FL.
FDA Recall
Terminated
·Biomet 3i, Inc.·Product code NHA·February 6, 2008
BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL.
FDA Recall
Terminated
·Biomet 3i, Inc.·Product code DZE·February 7, 2008
BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL
FDA Recall
Terminated
·Biomet 3i, Inc.·Product code NHA·February 14, 2008
BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA003, 3.0mm, BioMet 3i , Palm Beach, FL.
FDA Recall
Terminated
·Biomet 3i, Inc.·Product code DZE·February 7, 2008
DENTAL LOCATOR
FDA Adverse Event
Injury
·BIOMET 3I·Product code NHA·December 16, 2022
Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
FDA Recall
Open, Classified
·Prismatik Dentalcraft, Inc.·Product code NHA·September 30, 2025
LARGE HEX SCREWDRIVER
FDA Adverse Event
Malfunction
·ZIMMER INC. (BIOMET 3I, LLC )·Product code HXX·April 24, 2018
ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455 Riverside Drive, Palm Beach Gardens, FL 33410 USA. Made in Switzerland. Twist drill for preparation of osteotomy during dental implant surgical drilling procedure.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code DZA·June 29, 2009
AKRALAB S.L.U.
Importer
🇪🇸 Spain·8 Manufacturers
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices
Wellkang Ltd
Authorized representative
259 Manufacturers·3500 Devices
RIOMAVIX LTD
Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices