FDA Product Code
FDA Product Code DZE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3640
510(k) Clearances — 1,549 records · page 4 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K171784 | Straumann Dental Implant System | Straumann USA, LLC | 2018-01-19 | Traditional | PDF ↗ |
| K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments | Mis Implants Technologies , Ltd. | 2017-12-28 | Traditional | PDF ↗ |
| K172560 | PREMIUM ONE Implant Systems | Sweden & Martina S.P.A. | 2017-12-21 | Traditional | PDF ↗ |
| K170392 | S.I.N. Implant System | S.I.N. Sistema DE Implante Nacional S.A. | 2017-12-01 | Traditional | PDF ↗ |
| K171185 | IR Type Implant System | Biotem Co., Ltd. | 2017-12-01 | Traditional | PDF ↗ |
| K172576 | BioHorizons Tapered Short Implants | BioHorizons Implant Systems, Inc. | 2017-11-22 | Traditional | PDF ↗ |
| K170398 | S.I.N. Dental Implant System | S.I.N. Sistema DE Implante Nacional S.A. | 2017-11-21 | Traditional | PDF ↗ |
| K171769 | Straumann PURE Ceramic Implants | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | 2017-11-14 | Traditional | PDF ↗ |
| K161923 | J2A SLA Dental Implant System | Kj Meditech Co., Ltd. | 2017-11-09 | Traditional | PDF ↗ |
| K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017-11-06 | Traditional | PDF ↗ |
| K172352 | TREFOIL System | Nobel Biocare AB | 2017-10-20 | Traditional | PDF ↗ |
| K170394 | Kisses Mini | Achimhai Medical Corporation | 2017-10-06 | Traditional | PDF ↗ |
| K171795 | Thommen Implant System | Thommen Medical AG | 2017-09-29 | Traditional | PDF ↗ |
| K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | Sterngold Dental, LLC | 2017-09-28 | Abbreviated | PDF ↗ |
| K162482 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device , Ltd. | 2017-09-15 | Traditional | PDF ↗ |
| K171126 | Implantium II | Dentium Co., Ltd. | 2017-09-07 | Abbreviated | PDF ↗ |
| K171027 | Dentis Dental Implant System | Dentis Co., Ltd. | 2017-09-06 | Traditional | PDF ↗ |
| K170031 | Internal Octa Implant System | Ebi, Inc. | 2017-08-31 | Traditional | PDF ↗ |
| K163385 | Cortex Dental Implant System | Cortex Dental Implants Industries , Ltd. | 2017-08-29 | Traditional | PDF ↗ |
| K160850 | Nucleoss Tpure Implant System | Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti | 2017-08-04 | Traditional | PDF ↗ |
| K162867 | MagDen Dental Implant System | Shinhung Mst Co., Ltd. | 2017-07-26 | Traditional | PDF ↗ |
| K162853 | Bonafix TWO - Dental Implant System | Bonafix Surgical and Dental Implants | 2017-07-14 | Traditional | PDF ↗ |
| K163194 | Neodent Implant System - GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2017-07-14 | Traditional | PDF ↗ |
| K170372 | SpiralTech Dental Implant System | Spiraltech Superior Dental Implants, Inc. | 2017-06-30 | Traditional | PDF ↗ |
| K162299 | Spiral Shape Dental Implant System | Gp Implants | 2017-06-22 | Traditional | PDF ↗ |
| K161177 | Axiom PX | Anthogyr Sas | 2017-06-15 | Abbreviated | PDF ↗ |
| K163060 | Deep Conical (DC) Implants and Accessories | Southern Implants (Pty), Ltd. | 2017-06-13 | Traditional | PDF ↗ |
| K163349 | MIS V3 Conical Connection Dental Implant System | Mis Implants Technologies , Ltd. | 2017-05-26 | Traditional | PDF ↗ |
| K170287 | Dental Implants OKTAGON Bone Level Tapered Design | Hager& Meisinger GmbH | 2017-05-24 | Traditional | PDF ↗ |
| K160398 | MRI Compatibility for Existing Zimmer Dental Implant Systems | Zimmer Dental, Inc. | 2017-05-17 | Traditional | PDF ↗ |
| K163557 | SS SA Fixture | Osstem Implant Co., Ltd. | 2017-05-15 | Traditional | PDF ↗ |
| K170135 | TREFOIL System | Nobel Biocare AB | 2017-05-11 | Traditional | PDF ↗ |
| K163640 | QZA and RS Dental Implant Systems | Trinon Titanium GmbH | 2017-05-03 | Abbreviated | PDF ↗ |
| K170211 | Insight Dental System | Insight Dental System | 2017-04-27 | Traditional | PDF ↗ |
| K170220 | OneQ-SL s-Clean Implant System | Dentis Co., Ltd. | 2017-04-27 | Traditional | PDF ↗ |
| K163088 | TSIII BA Fixture | Osstem Implant Co., Ltd. | 2017-04-21 | Traditional | PDF ↗ |
| K161743 | Etgar Dental Implant System | Etgar Medical Instruments, Ltd. | 2017-04-14 | Traditional | PDF ↗ |
| K160581 | K3PRO Konus Additional Abutments and Implants | Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG | 2017-03-24 | Traditional | PDF ↗ |
| K162308 | Noris Medical MBI-2mm Dental Implant System | Noris Medical , Ltd. | 2017-03-17 | Traditional | PDF ↗ |
| K161598 | NobelZygoma 0° | Nobel Biocare AB | 2017-03-14 | Traditional | PDF ↗ |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment | Straumann USA, LLC | 2017-03-08 | Traditional | PDF ↗ |
| K162073 | Dental Implants OKTAGON Tissue Level and Bone Level | Hager& Meisinger GmbH | 2017-02-24 | Traditional | PDF ↗ |
| K161987 | UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure | Dio Corporation | 2017-02-21 | Traditional | PDF ↗ |
| K162099 | IBS Implant System II | Innobiosurg Co., Ltd. | 2017-02-15 | Traditional | PDF ↗ |
| K161103 | US SA Implant System | Osstem Implant Co., Ltd. | 2017-02-02 | Traditional | PDF ↗ |
| K161593 | GMI Frontier Dental Implant System | Ilerimplant S.L | 2017-01-19 | Traditional | PDF ↗ |
| K160965 | SuperLine | Dentium Co., Ltd. | 2017-01-13 | Abbreviated | PDF ↗ |
| K161281 | Dentalis Bio Solution Implants | Dentalis Bio Solution Implants, LLC | 2017-01-11 | Traditional | PDF ↗ |
| K160536 | Chaorum Implant System | Medimecca Co., Ltd. | 2017-01-05 | Traditional | PDF ↗ |
| K160475 | Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 2016-12-14 | Traditional | PDF ↗ |
| K161244 | s-Clean OneQ-SL Narrow Implant System | Dentis Co., Ltd. | 2016-12-07 | Traditional | PDF ↗ |
| K163043 | Zeramex P6 Dental Implant System | Dentalpoint AG | 2016-11-30 | Special | PDF ↗ |
| K161497 | Dental Implants and Abutments | Ditron Precision, Ltd. | 2016-10-28 | Traditional | PDF ↗ |
| K153332 | ETIII SA Fixture System (O3.2mm) | Hiossen, Inc. | 2016-10-27 | Traditional | PDF ↗ |
| K151970 | KJ Mini Implant System | Kj Meditech Co., Ltd. | 2016-10-21 | Traditional | PDF ↗ |
| K161604 | OSSTEM Implant System | Osstem Implant Co., Ltd. | 2016-10-17 | Traditional | PDF ↗ |
| K153521 | IH Implant System | Sewonmedix, Inc. | 2016-10-14 | Traditional | PDF ↗ |
| K160060 | DMi Dental Implant System | Dmi Innovative Medical Technology , Ltd. | 2016-10-03 | Traditional | PDF ↗ |
| K160221 | Implance Dental Implant System, Implance Dental Abutment System | Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. | 2016-09-12 | Traditional | PDF ↗ |
| K142846 | BBX1, BBX2, BBX1MO, BBX1MC | Globaldental, Inc. | 2016-09-08 | Traditional | PDF ↗ |
| K160106 | LUNA DENTAL IMPLANT SYSTEM | Shinhung Mst Co., Ltd. | 2016-08-26 | Special | PDF ↗ |
| K151757 | IMMEDIATELOAD Dental Implant System | Immediateload S.A. | 2016-08-03 | Traditional | PDF ↗ |
| K152385 | Zeramex P6 Dental Implant System | Dentalpoint AG | 2016-07-27 | Traditional | PDF ↗ |
| K152787 | ST Internal Fixture System | T-Plus Implant Tech. Co., Ltd. | 2016-07-22 | Traditional | PDF ↗ |
| K151626 | ET III Bio-SA Fixture System | Hiossen, Inc. | 2016-07-21 | Traditional | PDF ↗ |
| K153268 | NR Line Implant System | Dentium Co., Ltd. | 2016-07-20 | Traditional | PDF ↗ |
| K160213 | s-Clean Tapered II RBM Implant System | Dentis Co., Ltd. | 2016-06-21 | Traditional | PDF ↗ |
| K152786 | A Plus Internal Fixture System | T-Plus Implant Tech. Co., Ltd. | 2016-06-07 | Traditional | PDF ↗ |
| K152576 | Anker II Dental Implant System | Alliance Global Technology Co., Ltd. | 2016-06-02 | Traditional | PDF ↗ |
| K160119 | NobelSpeedy Groovy | Nobel Biocare AB | 2016-06-02 | Traditional | PDF ↗ |
| K153099 | INCLUSIVE TAPERED IMPLANT SYSTEM | Prismatik Dentalcraft, Inc. | 2016-05-23 | Traditional | PDF ↗ |
| K153650 | Microdent Ektos Implant System | Implants Microdent System S.L | 2016-05-20 | Traditional | PDF ↗ |
| K153350 | IBS Implant System | Innobiosurg Co., Ltd. | 2016-05-09 | Traditional | PDF ↗ |
| K153111 | TOUAREG CloseFit UNP 2.75mmD | Adin Dental Implants Systems , Ltd. | 2016-05-06 | Traditional | PDF ↗ |
| K151391 | BTI Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2016-05-02 | Traditional | PDF ↗ |
| K153064 | Blue Sky Bio Zygomatic Implant System | Blue Sky Bio, LLC | 2016-04-29 | Traditional | PDF ↗ |
| K151588 | maxFit II Dental Implant System | Taiwan Implant Technology Company, Ltd. | 2016-04-25 | Traditional | PDF ↗ |
| K152836 | TREFOIL System | Nobel Biocare AB | 2016-04-11 | Traditional | PDF ↗ |
| K153043 | Noris Medical MBI Dental Implant System | Noris Medical , Ltd. | 2016-04-11 | Traditional | PDF ↗ |
| K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical , Ltd. | 2016-04-08 | Traditional | PDF ↗ |
| K153098 | KLOCKNER VEGA DENTAL IMPLANT SYSTEM | SOADCO, S.L. | 2016-04-08 | Abbreviated | PDF ↗ |
| K153639 | OneQ-SL s-Clean Implant System | Dentis Co., Ltd. | 2016-04-08 | Traditional | PDF ↗ |
| K153758 | Straumann Bone Level Tapered Implants | Institut Straumann AG | 2016-03-23 | Traditional | PDF ↗ |
| K152093 | NobelZygoma 45° | Nobel Biocare AB | 2016-03-16 | Traditional | PDF ↗ |
| K152555 | Dental Implant System | Ariabio International, Inc. | 2016-02-11 | Traditional | PDF ↗ |
| K153173 | MOR Implant System | Sterngold Dental, LLC | 2016-02-05 | Abbreviated | PDF ↗ |
| K152188 | QUAD Dental Implants and Prostheses | Dentack Impants, Ltd. | 2016-01-28 | Traditional | PDF ↗ |
| K152520 | Magicore System | Innobiosurg Co., Ltd. | 2016-01-25 | Traditional | PDF ↗ |
| K151328 | PURE Ceramic Implants | Straumann USA | 2016-01-11 | Traditional | PDF ↗ |
| K151916 | TRI Dental Implant System | Tri Dental Implants Int. AG | 2015-12-18 | Traditional | PDF ↗ |
| K142313 | OneQ-SL Implant System | Dentis Co., Ltd. | 2015-12-10 | Traditional | PDF ↗ |
| K150571 | 3i T3 Short Implants | Biomet 3i | 2015-11-20 | Traditional | PDF ↗ |
| K150388 | Dental Implant System | Bio Concept Co., Ltd. | 2015-11-12 | Traditional | PDF ↗ |
| K151928 | PUR Dental Implant System | Sterngold Dental, LLC | 2015-11-06 | Abbreviated | PDF ↗ |
| K143142 | JDENTALCARE Implant System | Jdentalcare Srl | 2015-11-06 | Traditional | PDF ↗ |
| K151599 | iSy Implant System | Altatec GmbH | 2015-10-02 | Traditional | PDF ↗ |
| K142557 | Anker Dental Implant System - SB-III, ST and AT series | Alliance Global Technology Co., Ltd. | 2015-09-21 | Traditional | PDF ↗ |
| K143539 | Dental Implant OKTAGON Bone Level | Hager& Meisinger GmbH | 2015-08-31 | Traditional | PDF ↗ |
| K150040 | Implanova | Dental Evolutions, Inc. | 2015-08-27 | Traditional | PDF ↗ |
| K143758 | PerioType Rapid | Clinical House Europe GmbH | 2015-08-07 | Traditional | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.