meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
31
Latest Decision
2013-11-22

Clearances · page 31 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K132443 PIEZON 150 E.M.S Electro Medical Systems S.A ELC Class II 2013-11-22
K132258 ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM Zimmer Dental, Inc. DZE Class II 2013-11-19
K131165 ANKER DENTAL IMPLANT SYSTEM Alliance Global DZE Class II 2013-11-14
K130829 IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS Iq Implants , Ltd. DZE Class II 2013-11-14
K131753 MERIDIAN Ab Ardent EBF Class II 2013-11-14
K132102 BECE CAD ZIRKON HT+ Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO EIH Class II 2013-11-12
K130419 PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM Genoray Co., Ltd. MUH Class II 2013-11-06
K131693 RAYSCAN A-EXPERT Ray Co., Ltd. MUH Class II 2013-11-01
K132450 CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND Kuraray Noritake Dental, Inc. KLE Class II 2013-11-01
K123514 CLEARPATH ALIGNER Qserve America, Inc. NXC Class II 2013-11-01
K132109 ENAMELAST Ultradent Products Inc. / Oratech, LLC LBH Class II 2013-11-01
K132209 IPS E.MAX CAD ABUTMENT SOLUTIONS Ivoclar Vivadent, AG NHA Class II 2013-10-31
K131748 OSSEOFUSE DENTAL IMPLANT SYSTEM Osseofuse, Inc. DZE Class II 2013-10-31
K123155 LUNA DENTAL IMPLANT SYSTEM Shinhung Mst Co., Ltd. DZE Class II 2013-10-31
K130534 DIPLOMAT Diplomat Dental S.R.O. EIA Class I 2013-10-30
K132325 GUIDOR BIORESORBABLE MATRIX BARRIER Sunstar Americas, Inc. NPK Class II 2013-10-29
K130999 OSSEOSPEED PROFILE EV Dentsply Implants Manufacturing GmbH DZE Class II 2013-10-25
K122295 CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS Core 3D Protech, S.L. NHA Class II 2013-10-24
K132255 ULTRACEM Ultradent Products Inc. / Oratech, LLC EMA Class II 2013-10-24
K130198 NEO DENTA ZIRCONIA Neo Group Limited EIH Class II 2013-10-21
K130504 ASA ORAL APPLIANCES American Sleep Association LRK Class II 2013-10-18
K130601 BIOROOT RCS Novocol, Inc. KIF Class II 2013-10-17
K132145 MTM(R) CLEAR ALIGNER Dentsply International, Inc. NXC Class II 2013-10-11
K131534 KATANA ZIRCONIA Kuraray Noritake Dental, Inc. EIH Class II 2013-10-11
K130834 R7 Cefla S.C. ELC Class II 2013-10-08
K132141 BEAUTIFIL BULK FLOWABLE Shofu Dental Corporation EBF Class II 2013-10-03
K131042 LEDEX Dentmate Technology Co. , Ltd. EBZ Class II 2013-10-03
K132600 FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING Biomet Microfixation JEY Class II 2013-10-02
K131396 WIRED MOUTH PROTECTOR (WMP) Elba Laboratories, Inc. PFL Class I 2013-09-30
K131385 EASY-GRAFT Degradable Solutions AG LYC Class II 2013-09-27
K130560 MASTERTORQUE LUX 8900 L Kaltenbach & Voigt GmbH EFB Class I 2013-09-27
K130455 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES Dentalez Group, Stardental Division EFB Class I 2013-09-25
K131289 I-GEN Megagen Implant Co., Ltd. JEY Class II 2013-09-25
K123402 DIAGNOCAM Kaltenbach & Voigt GmbH NTK Class II 2013-09-24
K130654 CRYSTAL ULTRA Dental Laboratory Milling Supplies, LLC (Dlms) EIH Class II 2013-09-24
K131526 SFI-BAR Cendres & Metaux SA NHA Class II 2013-09-23
K130840 SMARTBUILDER SYSTEM (SB1) Osstem Implant Co., Ltd. JEY Class II 2013-09-18
K124025 ALPHA-PRO WHITE VARNISH Dental Technologies, Inc. LBH Class II 2013-09-18
K113738 CREODENT SOLIDEX CUSTOM ABUTMENT Creodent Prosthetics, Ltd. NHA Class II 2013-09-17
K131578 IPROPHY MOBILE Nakanishi, Inc. EKX Class I 2013-09-12
K130604 UNIVERSAL PASTE STAINS AND GLAZE Prismatik Dentalcraft, Inc. EIH Class II 2013-09-12
K130841 SHOFU BLOCK HC Shofu Dental Corporation EBF Class II 2013-09-11
K131043 APEX UNIVERSAL ADHESIVE Apex Dental Materials, Inc. KLE Class II 2013-09-10
K131138 RESPIRE PINK SERIES - HERBST Respire Medical LRK Class II 2013-09-09
K131442 FIRECR DENTALIMAGING SYSTEM 3Disc Americas MUH Class II 2013-09-06
K131357 PEAK Z Ultradent Products, Inc. KLE Class II 2013-09-06
K131701 Z5MLB, Z5MLC Z-Systems AG DZE Class II 2013-09-05
K131430 CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL Kuraray Noritake Dental, Inc. KLE Class II 2013-08-30
K131068 TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID Kuraray Noritake Dental, Inc. EJK Class II 2013-08-27
K131197 EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS Dental Morelli NJM Class II 2013-08-27
K130462 PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT Paltop Advanced Dental Solutions, Ltd. DZE Class II 2013-08-27
K131049 ZRP Apex Dental Materials, Inc. KLE Class II 2013-08-27
K131376 SMARTCOAT 2.5% NAF VARNISH Elevate Oral Care LBH Class II 2013-08-27
K131212 PREMIER CERAMIC PRIMER Premier Dental Products Co. KLE Class II 2013-08-26
K131101 ITERO SOFTWARE Cadent, Ltd. an Align Technology Company NHA Class II 2013-08-26
K130130 ATG/SM-OSA APPLIANCES Selane Products, Inc. LQZ Class II 2013-08-26
K130137 BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER Coltene/Whaledent ELC Class II 2013-08-23
K131097 LEGACY3 6MM LENGTH IMPLANTS Implant Direct Sybron Manufacturing, LLC DZE Class II 2013-08-22
K131432 CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL Kuraray Noritake Dental, Inc. KLE Class II 2013-08-22
K131451 PALTOP DENTAL IMPLANT - STERILE ACCESSORIES Paltop Advanced Dental Solutions, Ltd. DZE Class II 2013-08-22
K130076 PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS Merz Dental GmbH EBI Class II 2013-08-22
K130436 MULTILINK HYBRID ABUTMENT CEMENT Ivoclar Vivadent, AG EMA Class II 2013-08-20
K130163 D-LUX DiaDent Group International EBZ Class II 2013-08-16
K123582 ENDO A CLASS Saeyang Microtech Co., Ltd. EKX Class I 2013-08-16
K123608 ENDO E CLASS Saeyang Microtech Co., Ltd. EBW Class I 2013-08-16
K123988 ANYONETM INTERNAL IMPLANT SYSTEM Megagen Implant Co., Ltd. DZE Class II 2013-08-15
K130693 AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM Aseptico, Inc. ELC Class II 2013-08-14
K130421 MERON APPLICATION CAPSULES Voco GmbH EMA Class II 2013-08-14
K130672 OPTIFLOW II FLOWABLE COMPOSITE, LC Pac-Dent International, Inc. EBF Class II 2013-08-13
K130682 MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT Hager& Meisinger GmbH DZL Class II 2013-08-13
K131014 PANA SPRAY PLUS Nsk America Corp. EFB Class I 2013-08-12
K131674 PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING Biomet Microfixation JEY Class II 2013-08-08
K131345 TIARRAY DENTAL IMPLANT SYSTEM Nasseo, Inc. DZE Class II 2013-08-07
K130140 INTRA-LOCK OP DENTAL IMPLANT Intra-Lock International DZE Class II 2013-08-01
K130109 ENDOGRAPH DC Villa Sistemi Medicali S.P.A. EHD Class II 2013-08-01
K132041 REXTAR X Meta Biomed, Inc. EHD Class II 2013-07-31
K130949 CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS Biomet 3i DZE Class II 2013-07-30
K130680 ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS Dentsoll, Inc. EBI Class II 2013-07-26
K131117 ZIRMON SERIES Kuwotech Co., Ltd. EIH Class II 2013-07-26
K130410 DENTAL UNIT WITH CHAIR Xianyang North West Medical Instrument (Group) Co. EIA Class I 2013-07-26
K130125 MTA CEMENTS S&C Polymer Silicon- Und Composite Spezialitaeten KIF Class II 2013-07-24
K130862 CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM Dentsply Intl., Inc. ELC Class II 2013-07-23
K123631 MFP-051 GC America, Inc. EBF Class II 2013-07-23
K122988 KLOCKNER DENTAL IMPLANT ABUTMENTS SOADCO, S.L. NHA Class II 2013-07-19
K130088 PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM Genoray Co., Ltd. MUH Class II 2013-07-18
K113126 ACRYLIC HERBST APPLIANCE Gergens Orthodontic Lab LRK Class II 2013-07-17
K131504 UNIVERSAL OPAQUE Shofu Dental Corporation EBF Class II 2013-07-16
K130186 DENTEK EASY BRUSH WITH FLUORIDE Den Tek Oral Care, Inc. EFW Class I 2013-07-15
K130585 PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH Co., Ltd. MUH Class II 2013-07-15
K131036 YAMAHACHI DENTURE BASE RESINS Yamahachi Dental Manufacturing Co. EBI Class II 2013-07-12
K131248 ETCH GEL Dmg America, LLC KLE Class II 2013-07-11
K121310 MESOTHELIUM DENTAL MEMBRANE Kensey Nash Corporation NPL Class II 2013-07-11
K130183 SFI BAR ABUTMENTS Sterngold Dental, LLC NHA Class II 2013-07-07
K123471 ETII SA FIXTURE SYSTEM Hiossen, Inc. DZE Class II 2013-07-05
K122424 ISUS IMPLANT SUPRASTRUCTURES Dentsply International, Inc. NHA Class II 2013-07-05
K130920 CORRECT PLUS 1 Pentron Clinical ELW Class II 2013-07-02
K130408 ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT Sterngold Dental, LLC NHA Class II 2013-07-01
K123627 ET SMARTFIT ABUTMENT Hiossen, Inc. NHA Class II 2013-06-28
K130808 STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS Straumann USA NHA Class II 2013-06-28
K130310 CERTAIN BELLATEK PROVISIONAL ABUTMENTS Biomet 3i NHA Class II 2013-06-21

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