meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
29
Latest Decision
2016-07-21

Clearances · page 25 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K160086 SHOFU Enamel Conditioner Shofu Dental Corporation EBF Class II 2016-07-21
K160144 rainbow LS Block Genoss Co., Ltd. EIH Class II 2016-07-21
K151626 ET III Bio-SA Fixture System Hiossen, Inc. DZE Class II 2016-07-21
K152113 BioHPP - breCAM.BioHPP Bredent GmbH & Co. KG EBF Class II 2016-07-21
K153268 NR Line Implant System Dentium Co., Ltd. DZE Class II 2016-07-20
K160425 CAD/CAMouflage Milling Bock Prismatik Dentalcraft, Inc. EBF Class II 2016-07-15
K153230 ShefaBone SCPC Resorbable Bone Graft The Implantech Inc./Shefabone LYC Class II 2016-07-14
K160102 Amber Mill Series and Amber Press Series Hass Corp. EIH Class II 2016-07-14
K160551 VALO Grand Ultradent Products, Inc. EBZ Class II 2016-07-13
K160123 Apinator Allen J. Moses, Dds, Ltd. LRK Class II 2016-07-12
K153325 Gradia Plus GC America, Inc. EBF Class II 2016-07-12
K153048 AcceleDent Aura Orthoaccel Technologies, Inc. OYH Class II 2016-07-08
K153231 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer GC America, Inc. EMA Class II 2016-07-06
K160441 Identic and KromaFaze Alginate Dental Impression Materials Kerr Corporation ELW Class II 2016-06-30
K153645 VITA ENAMIC Implant Solutions (IS) Vita Zahnfabrik H.Rauter GmbH Co. NHA Class II 2016-06-30
K153136 Initial LiSi Press GC America, Inc. EIH Class II 2016-06-30
K153177 Admira Fusion Flow Voco GmbH EBF Class II 2016-06-30
K153078 LED Curing Light GT-2000 Monitex Industrial Co., Ltd. EBZ Class II 2016-06-28
K153018 CELALUX 3 Voco GmbH EBZ Class II 2016-06-23
K160213 s-Clean Tapered II RBM Implant System Dentis Co., Ltd. DZE Class II 2016-06-21
K160458 BI IMAGE-X EVOLUTION Radiotecnologia Industrial S.A. DE C.V. EHD Class II 2016-06-20
K160498 Dentivera Milling Disc Dental Solutions, LLC EBI Class II 2016-06-15
K152786 A Plus Internal Fixture System T-Plus Implant Tech. Co., Ltd. DZE Class II 2016-06-07
K160474 DSM Biomedical Porcine Pericardium Dental Membrane Kensey Nash Corporation Dba Dsm Biomedical NPL Class II 2016-06-07
K153534 NobelProcera HT ML Full Contour Zirconia Crown Nobel Biocare AB ELL Class II 2016-06-06
K142130 ORAL BOND Steiner Laboratories EMA Class II 2016-06-06
K160905 Sonendo GentleWave System Sonendo, Inc. ELC Class II 2016-06-03
K153036 NobelDesign Software Nobel Biocare AB NHA Class II 2016-06-02
K160119 NobelSpeedy Groovy Nobel Biocare AB DZE Class II 2016-06-02
K160099 CEREC SpeedGlaze Sirona Dental Systems GmbH EIH Class II 2016-06-02
K152576 Anker II Dental Implant System Alliance Global Technology Co., Ltd. DZE Class II 2016-06-02
K160244 VARIOunite Thommen Medical AG NHA Class II 2016-06-02
K151987 DCI Edge Dental Chair with Operative Unit Dci KLC Class I 2016-06-01
K152826 NoCord Centrix, Inc. ELW Class II 2016-05-27
K152167 BIJOU Orthodontic Ceramic Bracket World Bio Tech Co., Ltd. NJM Class II 2016-05-27
K151540 MC BIO Supertack Tack 3mm, 4mm and 5mm Eli-Ka Technologies DZL Class II 2016-05-26
K153099 INCLUSIVE TAPERED IMPLANT SYSTEM Prismatik Dentalcraft, Inc. DZE Class II 2016-05-23
K152559 TruAbutment DS Truabutment NHA Class II 2016-05-20
K152103 IPS Style Ceram, IPS Style Ceram One, IPS Style Press Ivoclar Vivadent, AG EIH Class II 2016-05-20
K153650 Microdent Ektos Implant System Implants Microdent System S.L DZE Class II 2016-05-20
K153127 everX Posterior GC America, Inc. EBF Class II 2016-05-20
K153334 Oral-B 5% Sodium Fluoride Varnish Young Dental Manufacturing Co. 1, LLC LBH Class II 2016-05-20
K153490 DD medical polymers Dental Direkt GmbH EBG Class II 2016-05-13
K152443 Vericore Gradient Temporary Disc Whip Mix Corporation EBG Class II 2016-05-11
K153350 IBS Implant System Innobiosurg Co., Ltd. DZE Class II 2016-05-09
K153111 TOUAREG CloseFit™ UNP 2.75mmD Adin Dental Implants Systems , Ltd. DZE Class II 2016-05-06
K152956 Pulp Canal Sealer, Pulp Canal Sealer EWT Sybron Dental Specialties KIF Class II 2016-05-06
K151391 BTI Dental Implant System UnicCa B.T.I. Biotechnology Institute, Sl. DZE Class II 2016-05-02
K153064 Blue Sky Bio Zygomatic Implant System Blue Sky Bio, LLC DZE Class II 2016-04-29
K152086 3Shape Ortho System 3Shape A/S PNN Class II 2016-04-28
K152927 BRILLIANT EVERGLOW Coltene/Whaledent AG EBF Class II 2016-04-28
K151588 maxFit II Dental Implant System Taiwan Implant Technology Company, Ltd. DZE Class II 2016-04-25
K153590 AvaDent Denture Base Material Global Dental Science EBI Class II 2016-04-22
K151731 Rainbow Paste Stain Genoss EIH Class II 2016-04-15
K160788 RIOScan (RPS500) Ray Co., Ltd. MUH Class II 2016-04-15
K153624 Neodent Implant System Jjgc Industria E Comercio DE Materiais Dentarios S NHA Class II 2016-04-15
K152959 Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes Sybron Dental Specialties KIF Class II 2016-04-14
K151608 4plus6Line Abutment System Ot Medical GmbH NHA Class II 2016-04-13
K153174 Ketac Universal Aplicap 3M Deutschland GmbH EMA Class II 2016-04-13
K153753 TelioCAD Multi Ivoclar Vivadent, Inc. EBG Class II 2016-04-12
K152836 TREFOIL System Nobel Biocare AB DZE Class II 2016-04-11
K153043 Noris Medical MBI Dental Implant System Noris Medical , Ltd. DZE Class II 2016-04-11
K151909 Noris Medical Zygomatic Dental Implant System Noris Medical , Ltd. DZE Class II 2016-04-08
K153411 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece Dentalez, Inc. EFB Class I 2016-04-08
K153098 KLOCKNER VEGA DENTAL IMPLANT SYSTEM SOADCO, S.L. DZE Class II 2016-04-08
K153639 OneQ-SL s-Clean Implant System Dentis Co., Ltd. DZE Class II 2016-04-08
K152652 PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement Gaia Dental Products, Inc. EMA Class II 2016-04-05
K153249 Pulpdent Solo Flowable Composite with MCP Pulpdent Corporation EBF Class II 2016-04-01
K153291 SICAT OPTISLEEP Sicat GmbH & Co. KG LRK Class II 2016-03-31
K153779 Abutment for Bridges Altatec GmbH NHA Class II 2016-03-31
K153767 X-cera Zirconia Blanks Shenzhen Xiangtong Photoelectricity Technology Co., Ltd. EIH Class II 2016-03-29
K152274 MSCB-001 GC America, Inc. EIH Class II 2016-03-25
K150702 Exceed Tx Great Lakes Orthodontics, Ltd. DYW Class II 2016-03-24
K153758 Straumann Bone Level Tapered Implants Institut Straumann AG DZE Class II 2016-03-23
K152051 ClearMet Mycone Dental Supply Co., T/A Keystone Industries EBI Class II 2016-03-22
K150566 Oniris Sas Oniris LRK Class II 2016-03-21
K160234 OVENT Oventus Manufacturing Pty, Ltd. LRK Class II 2016-03-17
K152093 NobelZygoma 45° Nobel Biocare AB DZE Class II 2016-03-16
K152845 Allied Biocompat Abutment for Nobel Replace Interface Allied Dental Solutions NHA Class II 2016-03-14
K151965 Dentti System Martz, Inc. NXC Class II 2016-03-11
K151748 Clean & More 3M Deutschland GmbH PIP Class II 2016-03-11
K151984 Thommen Milling Abutment for CAD/CAM Thommen Medical AG NHA Class II 2016-03-10
K160386 ReadeR, VieweR, QuickScan PSP Trident S.R.L MUH Class II 2016-03-10
K152766 CharmFlex Dentkist, Inc. ELW Class II 2016-03-08
K152861 Aquasil Ultra + Smart Wetting Impression Material Dentply International, Inc. ELW Class II 2016-03-04
K151590 Straumann RN Gold Abutment for Bridge Straumann USA, LLC NHA Class II 2016-03-04
K151789 LOCATOR F-Tx Attachment System Zest Anchors, LLC NHA Class II 2016-03-04
K153253 GC Reline II GC America, Inc. EBI Class II 2016-03-03
K151700 BEAUTIFIL II Gingiva Shofu Dental Corporation EBF Class II 2016-03-02
K153191 Calcium Bridge Denali Corporation EBF Class II 2016-02-26
K152691 EDS Universal Cement Essential Dental Systems, Inc. EMA Class II 2016-02-25
K151439 ATLANTIS ISUS Dentsply International, Inc. NHA Class II 2016-02-19
K151945 Triumph Resin Dam Denali Corporation EIE Class I 2016-02-18
K152555 Dental Implant System Ariabio International, Inc. DZE Class II 2016-02-11
K153144 TIO-H DIGITAL RADIOGRAPHY SENSOR Denttio, Inc. MUH Class II 2016-02-10
K152297 OBS Anchorage Screw Bomei Co, Ltd. OAT Class II 2016-02-09
K153173 MOR Implant System Sterngold Dental, LLC DZE Class II 2016-02-05
K151912 AIR-FLOW handy 3.0 PLUS E.M.S Electro Medical Systems S.A EFB Class I 2016-02-03
K152247 ATLANTIS Crown Dentsply International, Inc. EIH Class II 2016-01-29
K153157 Sonendo Gentle Wave System Sonendo, Inc. ELC Class II 2016-01-29

12,679 clearances in the Dental panel. Data: openFDA.