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 |
|---|---|---|---|
| Dec 14, 2016 | K160475 | Ritter Dental Implant System Ritter Implants GmbH & Co. KG, DE | DZE |
| Dec 7, 2016 | K161244 | s-Clean OneQ-SL Narrow Implant System Dentis Co., Ltd., KR | DZE |
| Nov 30, 2016 | K163043 | Zeramex P6 Dental Implant System Dentalpoint AG, CH | DZE |
| Oct 28, 2016 | K161497 | Dental Implants and Abutments Ditron Precision, Ltd., IL | DZE |
| Oct 27, 2016 | K153332 | ETIII SA Fixture System (O3.2mm) Hiossen, Inc. | DZE |
| Oct 21, 2016 | K151970 | KJ Mini Implant System Kj Meditech Co., Ltd., KR | DZE |
| Oct 17, 2016 | K161604 | OSSTEM Implant System Osstem Implant Co., Ltd., KR | DZE |
| Oct 14, 2016 | K153521 | IH Implant System Sewonmedix, Inc., KR | DZE |
| Oct 3, 2016 | K160060 | DMi Dental Implant System Dmi Innovative Medical Technology , Ltd., IL | DZE |
| Sep 12, 2016 | K160221 | Implance Dental Implant System, Implance Dental Abutment System Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti., TR | DZE |
| Sep 8, 2016 | K142846 | BBX1, BBX2, BBX1MO, BBX1MC Globaldental, Inc. | DZE |
| Aug 26, 2016 | K160106 | LUNA DENTAL IMPLANT SYSTEM Shinhung Mst Co., Ltd., KR | DZE |
| Aug 3, 2016 | K151757 | IMMEDIATELOAD Dental Implant System Immediateload S.A., CH | DZE |
| Jul 27, 2016 | K152385 | Zeramex P6 Dental Implant System Dentalpoint AG, CH | DZE |
| Jul 22, 2016 | K152787 | ST Internal Fixture System T-Plus Implant Tech. Co., Ltd., TW | DZE |
| Jul 21, 2016 | K151626 | ET III Bio-SA Fixture System Hiossen, Inc. | DZE |
| Jul 20, 2016 | K153268 | NR Line Implant System Dentium Co., Ltd., KR | DZE |
| Jun 21, 2016 | K160213 | s-Clean Tapered II RBM Implant System Dentis Co., Ltd., KR | DZE |
| Jun 7, 2016 | K152786 | A Plus Internal Fixture System T-Plus Implant Tech. Co., Ltd., TW | DZE |
| Jun 2, 2016 | K160119 | NobelSpeedy Groovy Nobel Biocare AB, SE | DZE |
| Jun 2, 2016 | K152576 | Anker II Dental Implant System Alliance Global Technology Co., Ltd., TW | DZE |
| May 23, 2016 | K153099 | INCLUSIVE TAPERED IMPLANT SYSTEM Prismatik Dentalcraft, Inc. | DZE |
| May 20, 2016 | K153650 | Microdent Ektos Implant System Implants Microdent System S.L, ES | DZE |
| May 9, 2016 | K153350 | IBS Implant System Innobiosurg Co., Ltd., KR | DZE |
| May 6, 2016 | K153111 | TOUAREG CloseFit UNP 2.75mmD Adin Dental Implants Systems , Ltd., IL | DZE |
| May 2, 2016 | K151391 | BTI Dental Implant System UnicCa B.T.I. Biotechnology Institute, Sl., ES | DZE |
| Apr 29, 2016 | K153064 | Blue Sky Bio Zygomatic Implant System Blue Sky Bio, LLC | DZE |
| Apr 25, 2016 | K151588 | maxFit II Dental Implant System Taiwan Implant Technology Company, Ltd., TW | DZE |
| Apr 11, 2016 | K153043 | Noris Medical MBI Dental Implant System Noris Medical , Ltd., IL | DZE |
| Apr 11, 2016 | K152836 | TREFOIL System Nobel Biocare AB, SE | DZE |
| Apr 8, 2016 | K153639 | OneQ-SL s-Clean Implant System Dentis Co., Ltd., KR | DZE |
| Apr 8, 2016 | K153098 | KLOCKNER VEGA DENTAL IMPLANT SYSTEM SOADCO, S.L., AD | DZE |
| Apr 8, 2016 | K151909 | Noris Medical Zygomatic Dental Implant System Noris Medical , Ltd., IL | DZE |
| Mar 23, 2016 | K153758 | Straumann Bone Level Tapered Implants Institut Straumann AG, CH | DZE |
| Mar 16, 2016 | K152093 | NobelZygoma 45° Nobel Biocare AB, SE | DZE |
| Feb 11, 2016 | K152555 | Dental Implant System Ariabio International, Inc. | DZE |
| Feb 5, 2016 | K153173 | MOR Implant System Sterngold Dental, LLC | DZE |
| Jan 28, 2016 | K152188 | QUAD Dental Implants and Prostheses Dentack Impants, Ltd., IL | DZE |
| Jan 25, 2016 | K152520 | Magicore System Innobiosurg Co., Ltd., KR | DZE |
| Jan 11, 2016 | K151328 | PURE Ceramic Implants Straumann USA | DZE |
| Dec 18, 2015 | K151916 | TRI Dental Implant System Tri Dental Implants Int. AG, CH | DZE |
| Dec 10, 2015 | K142313 | OneQ-SL Implant System Dentis Co., Ltd., KR | DZE |
| Nov 20, 2015 | K150571 | 3i T3 Short Implants Biomet 3i | DZE |
| Nov 12, 2015 | K150388 | Dental Implant System Bio Concept Co., Ltd., CN | DZE |
| Nov 6, 2015 | K151928 | PUR Dental Implant System Sterngold Dental, LLC | DZE |
| Nov 6, 2015 | K143142 | JDENTALCARE Implant System Jdentalcare Srl, IT | DZE |
| Oct 2, 2015 | K151599 | iSy Implant System Altatec GmbH, DE | DZE |
| Sep 21, 2015 | K142557 | Anker Dental Implant System - SB-III, ST and AT series Alliance Global Technology Co., Ltd., TW | DZE |
| Aug 31, 2015 | K143539 | Dental Implant OKTAGON Bone Level Hager& Meisinger GmbH, DE | DZE |
| Aug 27, 2015 | K150040 | Implanova Dental Evolutions, Inc. | DZE |
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