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)
Top companies in DZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Nobel Biocare AB | 33 | 37 |
| Biomet 3i | 11 | 52 |
| Nobelpharma AB | 52 | 0 |
| Zimmer Dental, Inc. | 19 | 30 |
| Straumann USA | 35 | 9 |
| Implant Innovations, Inc. | 37 | 4 |
| Steri-Oss, Inc. | 40 | 0 |
| BioHorizons Implant Systems, Inc. | 26 | 12 |
| Minimatic Implant Technology | 34 | 0 |
| Implant Center of the Palm Beaches | 32 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2014 | Zimmer, Inc. Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component. Terminated |
DZE | K011028 K013227 |
| Jul 14, 2014 | Zimmer, Inc. Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006 Terminated |
DZE | K101880 K101977 |
| Apr 15, 2014 | Biomet 3i, LLC BIOMET 3i Endosseous Dental Implant. Terminated |
DZE | None listed |
| Feb 20, 2014 | BioHorizons 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 |
DZE | K030463 |
| Feb 6, 2014 | Zest 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 |
DZE | K072878 K994257 |
| Jan 28, 2014 | Zimmer 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 |
DZE | K072589 |
| Sep 16, 2013 | Biomet 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 |
DZE | K063341 |
| Sep 16, 2013 | Biomet 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 |
DZE | K100724 |
| Aug 13, 2013 | Biomet 3i, LLC Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L) Terminated |
DZE | K122300 |
| Aug 13, 2013 | Biomet 3i, LLC Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L) Terminated |
DZE | K122300 |
| Dec 19, 2012 | BioHorizons Implant Systems Inc Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244.
Dental. Terminated |
DZE | None listed |
| Dec 19, 2012 | BioHorizons Implant Systems Inc AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244.
Dental. Terminated |
DZE | K993493 |
| Nov 16, 2012 | Biomet 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 |
DZE | K100724 |
| Nov 16, 2012 | Biomet 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 |
DZE | K100724 |
| Oct 23, 2012 | Biomet 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 |
DZE | K063341 |
| Jun 20, 2012 | Biomet 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 |
DZE | K063341 |
| May 10, 2012 | Zimmer 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 |
DZE | K112160 |
| May 10, 2012 | Zimmer 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 |
DZE | K112160 |
| May 10, 2012 | Zimmer 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 |
DZE | K112160 |
| May 10, 2012 | Zimmer 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 |
DZE | K112160 |
| May 10, 2012 | Zimmer 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 |
DZE | K112160 |
| May 10, 2012 | Zimmer 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 |
DZE | K112160 |
| Nov 8, 2011 | Biomet 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 |
DZE | K100724 |
| Nov 4, 2010 | BioHorizons 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 |
DZE | K053152 |
| May 27, 2010 | 3m Imtec Corporation S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head Terminated |
DZE | K031106 |
| Mar 26, 2010 | Pro-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 |
DZE | K991283 |
| Feb 22, 2010 | Biomet 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 |
DZE | K012911 |
| Dec 10, 2009 | Zimmer Inc. Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT. Terminated |
DZE | K061410 |
| Dec 1, 2008 | Zest 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 |
DZE | K994257 |
| Sep 19, 2008 | Nobel 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 |
DZE | K050258 K050705 |
| Sep 16, 2008 | Straumann 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 |
DZE | None listed |
| Feb 7, 2008 | Biomet 3i, Inc. BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA003, 3.0mm, BioMet 3i , Palm Beach, FL. Terminated |
DZE | None listed |
| Feb 7, 2008 | Biomet 3i, Inc. BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL. Terminated |
DZE | K012911 |
| Sep 18, 2007 | Biomet 3i Product is labeled as LTX XP Miniplant, Dental Implant, Sterile. Terminated |
DZE | K063286 K950204 |
| Jul 24, 2007 | Thommen Medical, AG SPI EASY Abutment. Endosseous dental implant abutment. Terminated |
DZE | K023645 |
| Jul 23, 2007 | Biomedicare, Inc. Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4814W Terminated |
DZE | K041368 |
| Jun 19, 2007 | Biomet 3i Biomet 3 i, Disposable Twist Drills, Model Number DT2715. Terminated |
DZE | None listed |
| Jun 14, 2007 | Biomet 3i EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant. Terminated |
DZE | K934126 |
| May 16, 2007 | Biomet 3i Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36. Terminated |
DZE | K934126 |
| May 11, 2007 | BioHorizons 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 |
DZE | K041938 |
| Apr 13, 2007 | BioHorizons 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 |
DZE | None listed |
| Apr 13, 2007 | BioHorizons Implant Systems Inc BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only Terminated |
DZE | K963951 |
| Apr 13, 2007 | BioHorizons Implant Systems Inc BioHorizons 0.050 Hex Driver, Regular, REF 300-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only Terminated |
DZE | K963951 |
| Apr 13, 2007 | BioHorizons 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 |
DZE | K963951 |
| Dec 6, 2006 | BioHorizons Implant Systems Inc BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit Terminated |
DZE | K041938 |
| Dec 1, 2006 | Dentsply Friadent Ceramed XiVE S plus Screw Implant D3.0/L15, Model Number 26-0125, Friadent GmbH. (dental implant) Terminated |
DZE | K032750 |
| Dec 1, 2006 | Dentsply Friadent Ceramed XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant) Terminated |
DZE | K032750 |
| Dec 1, 2006 | Dentsply Friadent Ceramed XiVE S plus Screw Implant D3.0/L11, Model Number 26-0122, Friadent GmbH. (dental implant) Terminated |
DZE | K032750 |
| May 4, 2006 | Straumann Manufacturing Inc. Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm
Ref: 048.043 Terminated |
DZE | K960634 |
| Jul 7, 2005 | Straumann Manufacturing Inc RN synOcta Meso Abutment, crown margin 8.0mm, Ti
Article: 048.560 Terminated |
DZE | K020096 |
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