ClearanceBrief
Panels › Dental › Product code DZE · Class 2

Implant, Endosseous, Root-Form

Regulation 872.3640

19510(k)s in 12 months (1,550 all time)
2recalls in 12 months (212 all time)
192recalls that name a 510(k)
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Top companies in DZE

DateFirm and productCodeLinked 510(k)
Aug 2, 2014Zimmer, Inc.
Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
Terminated
DZEK011028
K013227
Jul 14, 2014Zimmer, Inc.
Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
Terminated
DZEK101880
K101977
Apr 15, 2014Biomet 3i, LLC
BIOMET 3i Endosseous Dental Implant.
Terminated
DZENone listed
Feb 20, 2014BioHorizons Implant Systems Inc
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
Terminated
DZEK030463
Feb 6, 2014Zest Anchors LLC
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
Terminated
DZEK072878
K994257
Jan 28, 2014Zimmer Dental Inc
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
Terminated
DZEK072589
Sep 16, 2013Biomet 3i, LLC
Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration
Terminated
DZEK063341
Sep 16, 2013Biomet 3i, LLC
Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth r
Terminated
DZEK100724
Aug 13, 2013Biomet 3i, LLC
Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)
Terminated
DZEK122300
Aug 13, 2013Biomet 3i, LLC
Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Terminated
DZEK122300
Dec 19, 2012BioHorizons Implant Systems Inc
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
Terminated
DZENone listed
Dec 19, 2012BioHorizons Implant Systems Inc
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
Terminated
DZEK993493
Nov 16, 2012Biomet 3i, LLC
Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partia
Terminated
DZEK100724
Nov 16, 2012Biomet 3i, LLC
Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means for prosthetic attachment in single tooth restoration
Terminated
DZEK100724
Oct 23, 2012Biomet 3i, LLC
Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single
Terminated
DZEK063341
Jun 20, 2012Biomet 3i, LLC
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE
Terminated
DZEK063341
May 10, 2012Zimmer Inc.
Zimmer Dental Trabecular Metal Implant, TMM4B13, 4.1mm x13MM; 3.5 mm implant TM, MTX Rx, Sterile R, , Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implant is designed to replace
Terminated
DZEK112160
May 10, 2012Zimmer Inc.
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 repl
Terminated
DZEK112160
May 10, 2012Zimmer Inc.
Zimmer Dental Trabecular Metal, TMM4B10 TM 4.1MM MTX FULL,10 MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implants are designed to repla
Terminated
DZEK112160
May 10, 2012Zimmer Inc.
Zimmer Dental Trabecular Metal, TMT4B13 TM 4.1MM MTX FULL,13 MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implants are designed to repla
Terminated
DZEK112160
May 10, 2012Zimmer Inc.
Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implants are designed to
Terminated
DZEK112160
May 10, 2012Zimmer Inc.
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 re
Terminated
DZEK112160
Nov 8, 2011Biomet 3i, LLC
***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n 08940 Cornella
Terminated
DZEK100724
Nov 4, 2010BioHorizons Implant Systems Inc
Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244. Endosseous dental implant healing abutment.
Terminated
DZEK053152
May 27, 20103m Imtec Corporation
S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head
Terminated
DZEK031106
Mar 26, 2010Pro-Dex Inc dba Dyna-Dent
Zimmer PTW4321 20 Ncm Dental Torque Wrench, QTY 1 Pro-Dex Inc, Irvine, CA 92614 The Dental Torque Wrench is used to fasten dental implant abutments during the placement of dental implants.
Terminated
DZEK991283
Feb 22, 2010Biomet 3i, LLC
LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile. BIOMET 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA. For
Terminated
DZEK012911
Dec 10, 2009Zimmer Inc.
Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.
Terminated
DZEK061410
Dec 1, 2008Zest Anchors Inc
"LOCATOR Abutment for 5.7 Screw-Vent & Compatibles." Zest Anchors, Inc. Product is sold for use with any Zimmer Dental 5.7 mm diameter Tapered Screw-Vent Implant. The product is used with supra-ging
Terminated
DZEK994257
Sep 19, 2008Nobel Biocare USA LLC
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 devic
Terminated
DZEK050258
K050705
Sep 16, 2008Straumann Manufacturing Inc.
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
Terminated
DZENone listed
Feb 7, 2008Biomet 3i, Inc.
BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA003, 3.0mm, BioMet 3i , Palm Beach, FL.
Terminated
DZENone listed
Feb 7, 2008Biomet 3i, Inc.
BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL.
Terminated
DZEK012911
Sep 18, 2007Biomet 3i
Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.
Terminated
DZEK063286
K950204
Jul 24, 2007Thommen Medical, AG
SPI EASY Abutment. Endosseous dental implant abutment.
Terminated
DZEK023645
Jul 23, 2007Biomedicare, Inc.
Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4814W
Terminated
DZEK041368
Jun 19, 2007Biomet 3i
Biomet 3 i, Disposable Twist Drills, Model Number DT2715.
Terminated
DZENone listed
Jun 14, 2007Biomet 3i
EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.
Terminated
DZEK934126
May 16, 2007Biomet 3i
Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36.
Terminated
DZEK934126
May 11, 2007BioHorizons Implant Systems Inc
Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243
Terminated
DZEK041938
Apr 13, 2007BioHorizons Implant Systems Inc
BioHorizons 0.050 Hex Driver, Regular, REF 134-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only. The product is part of a Prosthetic Instrumentation system Kit 51-K
Terminated
DZENone listed
Apr 13, 2007BioHorizons Implant Systems Inc
BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only
Terminated
DZEK963951
Apr 13, 2007BioHorizons Implant Systems Inc
BioHorizons 0.050 Hex Driver, Regular, REF 300-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only
Terminated
DZEK963951
Apr 13, 2007BioHorizons Implant Systems Inc
BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377.
Terminated
DZEK963951
Dec 6, 2006BioHorizons Implant Systems Inc
BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit
Terminated
DZEK041938
Dec 1, 2006Dentsply Friadent Ceramed
XiVE S plus Screw Implant D3.0/L15, Model Number 26-0125, Friadent GmbH. (dental implant)
Terminated
DZEK032750
Dec 1, 2006Dentsply Friadent Ceramed
XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant)
Terminated
DZEK032750
Dec 1, 2006Dentsply Friadent Ceramed
XiVE S plus Screw Implant D3.0/L11, Model Number 26-0122, Friadent GmbH. (dental implant)
Terminated
DZEK032750
May 4, 2006Straumann Manufacturing Inc.
Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043
Terminated
DZEK960634
Jul 7, 2005Straumann Manufacturing Inc
RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560
Terminated
DZEK020096

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