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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

Company510(k)sRecalls
Nobel Biocare AB3337
Biomet 3i1152
Nobelpharma AB520
Zimmer Dental, Inc.1930
Straumann USA359
Implant Innovations, Inc.374
Steri-Oss, Inc.400
BioHorizons Implant Systems, Inc.2612
Minimatic Implant Technology340
Implant Center of the Palm Beaches320
DateFirm and productCodeLinked 510(k)
May 2, 2017Implant Direct Sybron Manufacturing, LLC
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Terminated		 DZEK061319
Apr 17, 2017Ace Surgical Supply Co., Inc.
INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.
Terminated		 DZEK093518
Apr 13, 2017Keystone Dental Inc
Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
Terminated		 DZEK051614
Mar 20, 2017Zimmer Dental Inc
Tapered SwissPlus Implant System, Model No. SPB10
Terminated		 DZEK082639
Mar 8, 2017Biomet 3i, LLC
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
Terminated		 DZEK063286
Mar 3, 2017Implant Direct Sybron Manufacturing, LLC
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support
Terminated		 DZEK130572
Jan 28, 2017Implant Direct Sybron Manufacturing, LLC
SwishTapered Implant
Terminated		 DZEK090234
Jan 9, 2017Implant Direct Sybron Manufacturing, LLC
GoDirect Screw-Retaining Top Part Numbers: 4500-61
Terminated		 DZEK090234
Nov 15, 2016Implant Direct Sybron Manufacturing, LLC
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
Terminated		 DZEK090234
Oct 21, 2016Keystone Dental Inc
Keystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in supp
Terminated		 DZEK051614
Sep 8, 2016Anthogyr
Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of s
Terminated		 DZEK141450
Sep 8, 2016Anthogyr
Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of si
Terminated		 DZEK101913
Aug 12, 2016Biomet 3i, LLC
Certain Gingihue TM 15 degree Angled Post Dental implants
Terminated		 DZEK972444
Aug 12, 2016Biomet 3i, LLC
Certain Flat Implant Cover Screw Dental implants
Terminated		 DZEK063341
Aug 12, 2016Biomet 3i, LLC
Certain Cover Screw Dental implants
Terminated		 DZEK063341
Aug 12, 2016Biomet 3i, LLC
Certain Titanium Large Hexed Screw Dental implants
Terminated		 DZEK972444
Aug 12, 2016Biomet 3i, LLC
Certain Micromini Flat Implant Cover Screw Dental implants
Terminated		 DZEK063341
Aug 12, 2016Biomet 3i, LLC
Certain Locator Abutment Dental implants
Terminated		 DZEK012911
Aug 12, 2016Biomet 3i, LLC
Certain Implant Straight Cover Screw Dental implants
Terminated		 DZEK063341
Aug 12, 2016Biomet 3i, LLC
Certain Implant Cover Screw Dental implants
Terminated		 DZEK063341
Aug 12, 2016Biomet 3i, LLC
Locator Abutment Dental implants
Terminated		 DZEK012911
Aug 12, 2016Biomet 3i, LLC
Implant Cover Screw Dental implants
Terminated		 DZEK063286
Aug 12, 2016Biomet 3i, LLC
DAL-RO Threaded Female Dental implants
Terminated		 DZEK891613
Aug 12, 2016Biomet 3i, LLC
DAL-RO Abutment Dental implants
Terminated		 DZEK891613
Aug 12, 2016Biomet 3i, LLC
DAL-RO Housing, Female Assembly Dental implants
Terminated		 DZEK891613
Aug 12, 2016Biomet 3i, LLC
Cover Screw, Headless Dental implants
Terminated		 DZEK063286
Aug 12, 2016Biomet 3i, LLC
Cover Screw Dental implants
Terminated		 DZEK063286
Aug 12, 2016Biomet 3i, LLC
Provide Protection Cap Dental implants
Terminated		 DZEK934126
Aug 12, 2016Biomet 3i, LLC
Prep-tite Cap Dental implants
Terminated		 DZEK904228
Aug 12, 2016Biomet 3i, LLC
Pick-Up Impression Coping Dental implants
Terminated		 DZENone listed
Aug 12, 2016Biomet 3i, LLC
Locator Replacement Males 4pk Dental implants
Terminated		 DZEK012911
Aug 12, 2016Biomet 3i, LLC
Locator Replacement Housing Kit Dental implants
Terminated		 DZEK012911
Aug 12, 2016Biomet 3i, LLC
Locator Replacement Housing Dental implants
Terminated		 DZEK012911
Aug 12, 2016Biomet 3i, LLC
Locator Light Retention Replacement Males 4pk Dental implants
Terminated		 DZEK012911
Aug 12, 2016Biomet 3i, LLC
Locator Extra Light Retention Males 4pk Dental implants
Terminated		 DZEK012911
Aug 12, 2016Biomet 3i, LLC
Locator Extra Light Angled Replacement Males 4pk Dental implants
Terminated		 DZEK012911
Aug 12, 2016Biomet 3i, LLC
Locator Extended Range Males 4pk Dental implants
Terminated		 DZEK012911
Aug 12, 2016Biomet 3i, LLC
O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants
Terminated		 DZEK891613
Aug 12, 2016Biomet 3i, LLC
O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
Terminated		 DZEK891613
Aug 12, 2016Biomet 3i, LLC
O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants
Terminated		 DZEK891613
Aug 8, 2016Biomet 3i, LLC
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Terminated		 DZEK063341
Aug 2, 2016Implant Direct Sybron Manufacturing, LLC
RePlant Angled Abutment Part Number 6050-52-60
Terminated		 DZEK061319
Jul 18, 2016Medtronic Navigation, Inc.
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for preci
Terminated		 DZEK992937
Jul 14, 2016Straumann Manufacturing, Inc.
Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512
Terminated		 DZEK150938
Jul 14, 2016Straumann Manufacturing, Inc.
Straumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
Terminated		 DZEK150938
Jun 22, 2016Nobel Biocare Usa Llc
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw ar
Terminated		 DZENone listed
Mar 4, 2016Implant Direct Sybron Manufacturing, LLC
The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 4
Terminated		 DZEK090234
Feb 9, 2016Zimmer Dental Inc
IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading a
Terminated		 DZEK112160
Feb 9, 2016Zimmer Dental Inc
IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading a
Terminated		 DZEK112160
Feb 9, 2016Zimmer Dental Inc
IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading
Terminated		 DZEK112160

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