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 |
|---|---|---|---|
| Aug 7, 2015 | K143758 | PerioType Rapid Clinical House Europe GmbH, CH | DZE |
| Jul 31, 2015 | K150021 | Z5m(t) Z-Systems AG, CH | DZE |
| Jul 31, 2015 | K142813 | Biogensis Implant System-Kisses Biogenesis Co., Ltd., KR | DZE |
| Jul 24, 2015 | K150968 | TRU Dental Implant System Sterngold Dental, LLC | DZE |
| Jul 24, 2015 | K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants Straumann USA, LLC | DZE |
| Jul 24, 2015 | K150344 | Dentis Dental Implant System Dentis Co., Ltd., KR | DZE |
| Jul 21, 2015 | K150537 | MiNi Internal Implant System Megagen Implant Co., Ltd., KR | DZE |
| Jul 20, 2015 | K141777 | NEODENT IMPLANT SYSTEM Jjgc Industria E Comercio DE Materiais Dentarios S | DZE |
| Jul 16, 2015 | K143011 | 2014 InterActive/SwishActive System Implant Direct Sybron Manufacturing, LLC | DZE |
| Jun 29, 2015 | K150363 | NOVA Dental Implants System Nova Implants , Ltd., IL | DZE |
| Jun 15, 2015 | K150199 | Neodent Implant System Jjgc Industria E Comercio DE Materiais Dentarios S, BR | DZE |
| Jun 15, 2015 | K142751 | Chang Gung ComMed Series Dental Implant System Chang Gung Medical Technology Co., Ltd., TW | DZE |
| Jun 2, 2015 | K141188 | MICRODENT GENIUS IMPLANT SYSTEM Implant Microdent | DZE |
| May 14, 2015 | K143326 | T.A.G. Dental Implant System T.A.G. Medical Products Corporation, Ltd., IL | DZE |
| May 11, 2015 | K142260 | NobelActive Nobel Biocare AB, SE | DZE |
| Apr 23, 2015 | K150182 | Neodent Implant System- CM Drive Implants Jjgc Industria E Comercio DE Materiais Dentarios S, BR | DZE |
| Apr 2, 2015 | K150060 | J2A Dental Implant System, J2C Dental Implant System Kj Meditech Co., Ltd., KR | DZE |
| Apr 2, 2015 | K143353 | Hahn Tapered Implant System Prismatik Dentalcraft, Inc. | DZE |
| Mar 27, 2015 | K142426 | EBI External Implant System Ebi, Inc., KR | DZE |
| Mar 23, 2015 | K140806 | IBS IMPLANT SYSTEM Innobiosurg Co., Ltd. | DZE |
| Mar 20, 2015 | K142174 | BIOMATE DENTAL IMPLANT SYSTEM Biomate Medical Devices Technology Co., Ltd., TW | DZE |
| Mar 11, 2015 | K141159 | KONUS DENTAL IMPLANT SYSTEM Argon Med. Productions Vertriebs Gesellschaft Mbh | DZE |
| Feb 2, 2015 | K142242 | PREMIUM, SHELTA Implant Systems Sweden & Martina S.P.A., IT | DZE |
| Jan 28, 2015 | K133733 | WINSIX Implant System Biosaf IN S.R.L., IT | DZE |
| Jan 8, 2015 | K143022 | BioHorizons Tapered Internal Implants BioHorizons Implant Systems, Inc. | DZE |
| Jan 7, 2015 | K142667 | Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm Sterngold Dental, LLC | DZE |
| Dec 19, 2014 | K140440 | NORIS MEDICAL DENTAL IMPLANTS SYSTEM Noris Medical , Ltd., IL | DZE |
| Dec 12, 2014 | K140202 | TRAUSIM DENTAL IMPLANT SYSTEM Jiangsu Trausim Medical Instrument, CN | DZE |
| Dec 12, 2014 | K140091 | XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM Megagen Implant Co., Ltd. | DZE |
| Nov 21, 2014 | K133362 | SGS DENTAL IMPLANT Sgs International, Ltd. | DZE |
| Nov 12, 2014 | K140934 | HIOSSEN IMPLANT SYSTEM Hiossen, Inc. | DZE |
| Oct 31, 2014 | K140293 | TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM Adin Dental Implants Systems , Ltd., IL | DZE |
| Oct 30, 2014 | K140052 | J2I IMPLANT SYSTEM Kj Meditech Co., Ltd. | DZE |
| Oct 30, 2014 | K140051 | KJ EXTERNAL IMPLANT SYSTEM Kj Meditech Co., Ltd. | DZE |
| Oct 28, 2014 | K142082 | ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT Zimmer Dental, Inc. | DZE |
| Oct 17, 2014 | K140728 | MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR Ditron Precision, Ltd., IL | DZE |
| Sep 19, 2014 | K133050 | ONE PLUS IMPLANT SYSTEM Osseofuse, Inc. | DZE |
| Sep 17, 2014 | K141450 | AXIOM 2.8 Anthogyr Sas, FR | DZE |
| Aug 22, 2014 | K133592 | NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM Neodent USA, Inc. | DZE |
| Aug 21, 2014 | K133706 | ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM Zl Microdent-Attachment GmbH & Co. KG, DE | DZE |
| Aug 20, 2014 | K140878 | STRAUMANN BONE LEVEL TAPERED IMPLANT Straumann USA, LLC | DZE |
| Aug 20, 2014 | K140347 | ANKYLOS C/X IMPLANT SYSTEM Dentsply Intl., Inc. | DZE |
| Aug 12, 2014 | K133255 | ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS Dentalpoint AG, CA | DZE |
| Aug 6, 2014 | K133991 | ISY Altatec GmbH | DZE |
| Jul 3, 2014 | K132881 | Z5C Z-Systems AG | DZE |
| Jun 25, 2014 | K133327 | SATURNO(TM) OVERDENTURE IMPLANT SYSTEM Zest Anchors, LLC | DZE |
| Jun 19, 2014 | K130694 | JR IMPLANT SYSTEM LK Consulting Group USA, Inc. | DZE |
| Jun 13, 2014 | K133884 | BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM Biodenta Swiss AG, CH | DZE |
| Jun 13, 2014 | K122807 | DENTAL IMPLANT SYSTEM Hager& Meisinger GmbH | DZE |
| Jun 5, 2014 | K132956 | U FIT DENTAL IMPLANT SYSTEM T Strong, Inc. | DZE |
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