meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
35
Latest Decision
2014-10-22

Clearances · page 29 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K141544 ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM Zimmer Dental, Inc. NHA Class II 2014-10-22
K141724 UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK Liaoning Upcera Co., Ltd. EIH Class II 2014-10-22
K142670 Vericore Zirconia Blanks Whip Mix Corporation EIH Class II 2014-10-22
K141723 UPCERA COLORING LIQUID (I AND II ) Liaoning Upcera Co., Ltd. EIH Class II 2014-10-22
K140993 IONOSTAR MOLAR Voco GmbH EMA Class II 2014-10-20
K140728 MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR Ditron Precision, Ltd. DZE Class II 2014-10-17
K141165 MATRIXWAVE MMF SYSTEM Synthes (USA) Products, LLC JEY Class II 2014-10-17
K133390 NDX DORSAL APPLIANCE Institute For Quality Resource Management LRK Class II 2014-10-16
K133488 PIEZOMED W&H Dentalwerk Buermoos GmbH DZI Class II 2014-10-16
K141659 PRISM ZIRCONIA, ST-98 A & D Dental Innovations EIH Class II 2014-10-09
K131487 FLUOR PROTECTOR S Ivoclar Vivadent, AG LBH Class II 2014-10-08
K133040 LED CURING LIGHT Monitex Industrial Co., Ltd. EBZ Class II 2014-10-07
K140908 JUGGERKNOT MINI SOFT ANCHOR Biomet Sports Medicine DZL Class II 2014-10-02
K141422 PROFLUORO FLUORIDE VARNISH Pac-Dent International, Inc. LBH Class II 2014-09-30
K140349 STARBRIGHT 5% SODIUM FLUORIDE VARNISH Nanova Biomaterials, Inc. LBH Class II 2014-09-22
K133050 ONE PLUS IMPLANT SYSTEM Osseofuse, Inc. DZE Class II 2014-09-19
K133298 ENDO SMART Meta Biomed, Inc. EKX Class I 2014-09-19
K130312 IROOT FM Innovative Bioceramix, Inc. KIF Class II 2014-09-18
K141450 AXIOM 2.8 Anthogyr Sas DZE Class II 2014-09-17
K140758 M-PM-DISC (PINK) Merz Dental GmbH EBI Class II 2014-09-15
K141018 ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT Procter & Gamble Co. JEQ Class I 2014-09-15
K141439 ORTHODONTIC ACRYLIC (NOT FINALIZED) Bisco, Inc. EBI Class II 2014-09-12
K140429 CRANE ACRYLIC HERBST APPLIANCE Crane Dental Laboratory, Inc. LRK Class II 2014-09-11
K141562 MSN-006 GC America, Inc. EBG Class II 2014-09-05
K140013 SOPIX INSIDE, SOPIX2 INSIDE Sopro - Acteon Group MUH Class II 2014-09-05
K132245 AJAX DENTAL UNIT Pro Dental Services, LLC EIA Class I 2014-09-05
K141293 PHOT-X IIS MODEL 505 Takara Belmont Corporation EHD Class II 2014-09-03
K140877 VERICORE ZIRCONIA BLANKS Whip Mix Corp. EIH Class II 2014-09-03
K141162 ALL-CERAMIC ZIRCONIA BLOCK Rizhao Huge Dental Industry Co., Ltd. EIH Class II 2014-08-27
K141497 PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) Osstem Implant Co., Ltd. EHD Class II 2014-08-26
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 Class II 2014-08-22
K133706 ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM Zl Microdent-Attachment GmbH & Co. KG DZE Class II 2014-08-21
K140600 SB ANCHOR Osstem Implant Co., Ltd. NHA Class II 2014-08-21
K141788 OBSIDIAN MILLING BLOCKS Prismatik Dentalcraft, Inc. EIH Class II 2014-08-20
K140965 MULTIPIEZO PRO, MULTIPIEZO Mectron S.P.A. ELC Class II 2014-08-20
K140347 ANKYLOS C/X IMPLANT SYSTEM Dentsply Intl., Inc. DZE Class II 2014-08-20
K140878 STRAUMANN BONE LEVEL TAPERED IMPLANT Straumann USA, LLC DZE Class II 2014-08-20
K140537 TENURE4G Den-Mat Holdings, LLC KLE Class II 2014-08-20
K140507 HIOSSEN PROSTHETIC SYSTEM Osstem Implant Co., Ltd. NHA Class II 2014-08-20
K140966 VONFLEX S BITE Vericom Co., Ltd. ELW Class II 2014-08-15
K140308 MASTERSURG / EXPERTSURG Kaltenbach & Voigt GmbH EBW Class I 2014-08-15
K140737 STRAUMANN CARES SCREW RETAINED BARS/BRIDGE Straumann USA, LLC NHA Class II 2014-08-14
K133255 ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS Dentalpoint AG DZE Class II 2014-08-12
K141871 Straumann Bone Level NC Angled Screw Retained Abutments Straumann USA, LLC NHA Class II 2014-08-07
K133991 ISY Altatec GmbH DZE Class II 2014-08-06
K133461 STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM Stryker JEY Class II 2014-08-01
K141610 FUTURABOND M+ Voco GmbH KLE Class II 2014-08-01
K102973 SILVER DENTAL ARREST Cooley Consulting, Inc. PHR Class II 2014-07-31
K140894 ARGEN PMMA The Argen Corporation EBG Class II 2014-07-31
K141130 ENCOMPASS Panoramic Corp. MUH Class II 2014-07-30
K141120 ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM Zimmer Dental, Inc. NHA Class II 2014-07-29
K140777 ZQUIET-SA Sleeping Well, LLC LRK Class II 2014-07-25
K140281 FLEXI-LUME LED SYSTEM Epic Medical Concepts & Innovations EBZ Class II 2014-07-24
K133683 MICR02 OSA DEVICE Microdental, Inc. LRK Class II 2014-07-24
K132749 NOBELPROCERA OVERDENTURE BAR Nobel Biocare USA, LLC NHA Class II 2014-07-24
K140518 GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER Geistlich Pharma AG NPL Class II 2014-07-18
K133551 ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM Zimmer Dental, Inc. NHA Class II 2014-07-18
K140714 PORCINE ANORGANIC BONE MINERAL Collagen Matrix, Inc. NPM Class II 2014-07-16
K140976 ENADEN FLOW Km Corporation EBF Class II 2014-07-10
K140144 BENDA WEDGE Centrix, Inc. EJB Class I 2014-07-08
K132214 ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE Hager& Meisinger GmbH NHA Class II 2014-07-07
K132881 Z5C Z-Systems AG DZE Class II 2014-07-03
K140685 ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM Sybron Endo NYL Class I 2014-07-02
K140512 UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE Juno Dentistry LP EBF Class II 2014-07-02
K140132 BIODENTINE Septodont KIF Class II 2014-06-27
K140435 MEDLEY GOLD American Dental Sleep Medicine, Ip, LLC LRK Class II 2014-06-26
K141104 TRUKLEAR BRACKET Ajw Technology Consultants, Inc. NJM Class II 2014-06-25
K132115 ABSOLUTE DENTIN 2 Parkell, Inc. EBF Class II 2014-06-25
K133327 SATURNO(TM) OVERDENTURE IMPLANT SYSTEM Zest Anchors, LLC DZE Class II 2014-06-25
K140278 SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX Somnomed, Inc. LRK Class II 2014-06-20
K140644 PROCEM Ototronix, LLC NEA Class II 2014-06-19
K130694 JR IMPLANT SYSTEM LK Consulting Group USA, Inc. DZE Class II 2014-06-19
K132869 SILDENT Hrs Co., Ltd. ELW Class II 2014-06-19
K140570 CHAIRSIDE ATTACHMENT PROCESSING MATERIAL Zest Anchors, LLC EBI Class II 2014-06-16
K133884 BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM Biodenta Swiss AG DZE Class II 2014-06-13
K122807 DENTAL IMPLANT SYSTEM Hager& Meisinger GmbH DZE Class II 2014-06-13
K132003 WINX SLEEP THERAPY SYSTEM Apnicure, Inc. OZR Class II 2014-06-13
K140955 MTA2.1 MATERIAL Avalon Biomed, Inc. KIF Class II 2014-06-11
K134022 BASE IT Spident Co., Ltd. EJK Class II 2014-06-11
K134021 ESTEMP IMPLANT, ESTEMP CLEAR Spident Co., Ltd. EMA Class II 2014-06-10
K140374 MASTERGRAFT PUTTY Medtronic Sofamor Danek USA, Inc. LYC Class II 2014-06-10
K140924 STARCERAM H.C. Starck Ceramics GmbH EIH Class II 2014-06-05
K140602 FLASH PENTA MB QUICK, FLASH MB QUICK 3M Espe AG ELW Class II 2014-06-05
K132956 U FIT DENTAL IMPLANT SYSTEM T Strong, Inc. DZE Class II 2014-06-05
K140481 COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH Colgate-Palmolive Company LBH Class II 2014-06-05
K133850 CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) Prismatik Dentalcraft, Inc. EBF Class II 2014-06-04
K132585 ZIBONE CERAMIC DENTAL IMPLANT SYSTEM Coho Technology Co., Ltd. DZE Class II 2014-06-04
K132378 X-MIND UNITY De Gotzen S.R.L. EHD Class II 2014-05-30
K131319 T1/T2/T3 TURBINE FAMILY Sirona Dental Systems GmbH EFB Class I 2014-05-30
K132506 SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY Michael D Williams Dds PA LRK Class II 2014-05-29
K140190 NIGHT SHIFT Advanced Brain Monitoring, Inc. MYB Class II 2014-05-29
K133071 ELASTIC IMPRESSION MATERIAL Rizhao Huge Dental Industry Co., Ltd. ELW Class II 2014-05-28
K133776 A-DEC/W&H ELECTRIC HANDPIECE MOTOR A-Dec, Inc. EBW Class I 2014-05-28
K123876 SYNERGY Odontit S.A. NPM Class II 2014-05-22
K132937 HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) Harvest Dental Products, LLC EBG Class II 2014-05-21
K140074 HYGEDENT ALGINATE IMPRESSION MATERIAL Hygedent, Inc. ELW Class II 2014-05-21
K133304 RXG DISTRACTION SYSTEM KLS-Martin L.P. JEY Class II 2014-05-15
K133752 SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT Sonendo, Inc. ELC Class II 2014-05-15
K133206 Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM Zuma Dental, LLC MUH Class II 2014-05-13
K133042 ENDOCEM ZR Maruchi KIF Class II 2014-05-12

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