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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 14, 2010 | K093518 | ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM Ace Surgical Supply Co., Inc. | DZE |
| Jan 7, 2010 | K091182 | CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000 Champions Implants GmbH, DE | DZE |
| Jan 5, 2010 | K092555 | UNO NARROW IMPLANT Mis Implants Technologies , Ltd., IL | DZE |
| Dec 28, 2009 | K092674 | SIMPLER TOADSTOOL MINI IMPLANT Pan Global Implant, CA | DZE |
| Dec 15, 2009 | K093164 | 3.25 SPLINE TWIST IMPLANT, HA COATED Zimmer Dental, Inc. | DZE |
| Dec 8, 2009 | K091051 | BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM Tita-Link | DZE |
| Nov 24, 2009 | K093352 | HG III FIXTURE SYSTEM Hiossen, Inc. | DZE |
| Nov 10, 2009 | K092434 | STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM Sterngold | DZE |
| Oct 15, 2009 | K092035 | BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION Bicon, LLC | DZE |
| Oct 6, 2009 | K092112 | BTI DENTAL IMPLANT TINY 2.5-3.0 B.T.I. Biotechnology Institute, Sl., ES | DZE |
| Oct 6, 2009 | K091878 | OSSEOLINK DENTAL IMPLANT SYSTEM Global Implant Solutions, LLC | DZE |
| Oct 6, 2009 | K090716 | BEGO SEMADOS S-LINE Bego Implant Systems GmbH & Co. KG, DE | DZE |
| Sep 22, 2009 | K091239 | ASTRA TECH IMPLANT SYSTEM Astra Tech AB | DZE |
| Sep 16, 2009 | K092594 | ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX Ace Surgical Supply Co., Inc. | DZE |
| Sep 14, 2009 | K090174 | TSI; ERI Oco Biomedical | DZE |
| Aug 28, 2009 | K090377 | SINUS QUICK EB SYSTEM Neobiotech Co., Ltd. | DZE |
| Jul 29, 2009 | K090054 | ATLAS IMPLANT SYSTEM - WIDE PLUS Cowellmedi Co., Ltd. | DZE |
| Jul 27, 2009 | K090154 | SPI DENTAL IMPLANT INICELL Thommen Medical AG | DZE |
| Jul 23, 2009 | K083670 | UNIVERSAL, AESTHETICA, NATEA, NATURA Euroteknika, CA | DZE |
| Jul 16, 2009 | K090825 | SQ IS SYSTEM Neobiotech Co., Ltd. | DZE |
| Jul 14, 2009 | K090527 | SINUS QUICK IT SYSTEM Neobiotech Co., Ltd. | DZE |
| Jul 7, 2009 | K090709 | CORTEX DENTAL IMPLANT SYSTEM Cortex Dental Implants Industries , Ltd., IL | DZE |
| Jun 19, 2009 | K082843 | MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM Dentis Co., Ltd. | DZE |
| Jun 8, 2009 | K083669 | OBI Euroteknika, CA | DZE |
| May 22, 2009 | K090452 | NEOSS IMPLANT SYSTEM 03.25 Neoss, Ltd. | DZE |
| May 22, 2009 | K083805 | ANKYLOS C/X DENTAL IMPLANT SYSTEM Dentsply Intl., Inc. | DZE |
| May 19, 2009 | K090005 | BRANEMARK INTEGRATION BIOHELIX IMPLANTS Branemark Integration AB, SE | DZE |
| May 15, 2009 | K090234 | SPECTRA SYSTEM DENTAL IMPLANTS 2008 Implant Direct, LLC | DZE |
| May 1, 2009 | K083633 | HS II SHORT FIXTURE SYSTEM Osstem Implant Co., Ltd. | DZE |
| Apr 29, 2009 | K083586 | I-FIX SYSTEM Dentis Co., Ltd. | DZE |
| Apr 20, 2009 | K090049 | ATLAS IMPLANT SYSTEM- MINI PLUS Cowellmedi Co., Ltd. | DZE |
| Apr 17, 2009 | K090237 | HG II FIXTURE SYSTEM Hiossen, Inc. | DZE |
| Mar 27, 2009 | K083869 | BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI Btlock Srl, IT | DZE |
| Mar 27, 2009 | K081748 | ONEPLANT DENTAL IMPLANT SYSTEM Warantec Co., Ltd. | DZE |
| Mar 23, 2009 | K083886 | SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004 Simpler One Stop, CA | DZE |
| Mar 6, 2009 | K083543 | DENOVISMED DENTAL IMPLANT SYSTEMS Denovis Medical, LLC | DZE |
| Feb 26, 2009 | K090260 | MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS Straumann Manufacturing, Inc. | DZE |
| Feb 26, 2009 | K083550 | STRAUMANN DENTAL IMPLANT SYSTEM Straumann USA | DZE |
| Feb 20, 2009 | K081419 | STRAUMANN DENTAL IMPLANT SYSTEM Institut Straumann AG | DZE |
| Feb 13, 2009 | K083205 | NOBELACTIVE 8.5 MM & 18.0 MM Nobel Biocare AB | DZE |
| Feb 11, 2009 | K083561 | NEOSS PROACTIVE IMPLANT Neoss, Ltd. | DZE |
| Feb 2, 2009 | K083067 | MS SYSTEM Osstem Implant Co., Ltd. | DZE |
| Jan 30, 2009 | K083496 | CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS Altatec GmbH | DZE |
| Jan 28, 2009 | K083297 | PITT-EASY DENTAL IMPLANT SYSTEM Sybron Implant Solutions GmbH | DZE |
| Dec 22, 2008 | K082651 | ENDOSSEOUS DENTAL IMPLANT SYSTEM Southern Implants, Inc. | DZE |
| Dec 19, 2008 | K082639 | ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS Zimmer Dental, Inc. | DZE |
| Dec 19, 2008 | K081751 | ADIN DENTAL IMPLANTS SYSTEM Adin Dental Implants System, Ltd., IL | DZE |
| Dec 4, 2008 | K082749 | OMNI-TIGHT Basic Dental Implant Systems, Inc. | DZE |
| Nov 25, 2008 | K082838 | ORLUS MINI SCREW Ortholution Co., Ltd. | DZE |
| Nov 25, 2008 | K082200 | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 SOADCO, S.L., AD | DZE |
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