meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
37
Latest Decision
2013-01-16

Clearances · page 33 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K113246 OCS-B Nibec Company, Limited NPM Class II 2013-01-16
K122708 REMESENSE FOR SENSITIVE TEETH Sylphar N.V. LBH Class II 2013-01-14
K122391 MEDTRONIC XOMED, INC. Medtronic Xomed, Inc. LRK Class II 2013-01-10
K123396 I.FLEX BY TCS Thermoplastic Comfort Systems, Inc. EBI Class II 2013-01-10
K121621 SOLOCEM Coltene/Whaledent AG EMA Class II 2013-01-08
K122643 VANTAGE MODEL V5000, V5100, V5000C, V5100C Midmark Corp. MUH Class II 2013-01-07
K121585 TS IMPLANT SYSTEM Osstem Implant Co., Ltd. DZE Class II 2013-01-07
K113516 THERASOM-CAST Family Dental Services, P.C. LRK Class II 2013-01-04
K100695 COLLADENTAL BARRIER Collamatrix, Inc. NPL Class II 2013-01-03
K123419 EVA SELECT DIGITAL DENTAL IMAGING SYSTEM Afp Imaging Corp. MUH Class II 2012-12-27
K122039 KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B Kettenbach GmbH & Co. KG EBG Class II 2012-12-27
K123092 CERAMIN BRACKETS Z Tomy, Inc. NJM Class II 2012-12-21
K120822 STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST Institut Straumann AG NHA Class II 2012-12-21
K120793 Z-LOOK3 EVO SLM Z-Systems AG DZE Class II 2012-12-21
K123773 X-TRA BASE Voco GmbH EBF Class II 2012-12-21
K111105 CURASAN OSSEOLIVE DENTAL Curasan AG LYC Class II 2012-12-20
K111189 SYNTEC DENTAL IMPLANT Syntec Scientific Corp. DZE Class II 2012-12-20
K123695 TRAUS SIP10 Saeshin Precision Co., Ltd. EKY Class I 2012-12-18
K113779 CONELOG IMPLANT SYSTEM Altatec GmbH DZE Class II 2012-12-14
K121117 NDX ABUTMENTS National Dentex Corp NHA Class II 2012-12-14
K122753 EMPOWER CLEAR American Orthodontics NJM Class II 2012-12-14
K123094 ORTHODONTIC CERAMIC BRACKETS Tomy, Inc. NJM Class II 2012-12-13
K122269 ENAMIC Vita Zahnfabrik H.Rauter GmbH & Co. EIH Class II 2012-12-13
K123493 VEX-S 100W INTRAORAL X-RAY SYSTEM VATECH Co., Ltd. EHD Class II 2012-12-13
K120956 VSP SYSTEM Medical Modeling, Inc. DZJ Class II 2012-12-12
K122855 TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS Straumann USA DZE Class II 2012-12-12
K122268 ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS Dentsply International NHA Class II 2012-12-11
K122892 MTA2 ROOT AND PULP MATERIALS Avalon Biomed, Inc. KIF Class II 2012-12-11
K122421 TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID Kuraray Noritake Dental, Inc. EJK Class II 2012-12-11
K121620 ULTRASONIC SURGERY Dmetec.Co., Ltd. DZI Class II 2012-12-11
K121843 NP-CAST ABUTMENT SYSTEM Osstem Implant Co., Ltd. NHA Class II 2012-12-11
K120237 BPA-FREE MICROHYBID COMPOSITE Novocol, Inc. EBF Class II 2012-12-11
K121391 INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS Prismatik Dentalcraft, Inc. NHA Class II 2012-12-10
K122475 ZQUIET PRO-PLUS Sleeping Well, LLC LRK Class II 2012-12-07
K123278 IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF Heraeus Kulzer, LLC KLE Class II 2012-12-07
K123265 RMGI LOW VISCOSITY Pulpdent Corporation EMA Class II 2012-12-07
K123273 HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) Temrex Corp. EMA Class II 2012-12-07
K122582 DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) Denterprise International, Inc. EHD Class II 2012-12-07
K122322 PIEZOSURGERY TOUCH Mectron S.P.A. DZI Class II 2012-12-06
K122852 PHYSIOSTAR NFC Candulor USA, Inc. ELM Class II 2012-12-06
K120858 IMPLANT BAR Prismatik Dentalcraft, Inc. NHA Class II 2012-12-06
K121440 ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT Siesta Medical, Inc. ORY Class II 2012-12-06
K121995 TS FIXTURE SYSTEM Osstem Implant Co., Ltd. DZE Class II 2012-11-29
K123119 CERARESIN BOND Shofu Dental Corporation KLE Class II 2012-11-28
K122052 MINIFIX BALL MINIFIX ONE Bonafix Surgical and Dental Implants, LLC DZE Class II 2012-11-28
K122725 TANDA PEARL, ULTRAWYTE, PEARL Syneron Beauty EEG Class I 2012-11-27
K121093 D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 Dxm Co., Ltd. EBZ Class II 2012-11-27
K122467 3M TRUE DEFINITION SCANNER 3M Company NOF Class II 2012-11-20
K113567 SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM Synthes, Inc. JEY Class II 2012-11-19
K113113 ENDOSSEOUS DENTAL IMPLANT Ot Medical GmbH DZE Class II 2012-11-16
K122171 MS SA IMPLANT SYSTEM Osstem Implant Co., Ltd. DZE Class II 2012-11-16
K120873 ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM Zimmer Dental, Inc. NHA Class II 2012-11-08
K121814 ENCORE TONGUE SUSPENSION SYSTEM Siesta Medical, Inc. ORY Class II 2012-11-07
K120659 HU-FRIEDY DENTAL CARTRIDGE SYRINGE Hu-Friedy Mfg. Co., LLC EJI Class II 2012-11-06
K122192 NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM Straumann USA, LLC NHA Class II 2012-11-02
K122313 STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM Stryker JEY Class II 2012-10-31
K122130 WINX SLEEP THERAPY SYSTEM Apnicure, Inc. OZR Class II 2012-10-31
K112139 THE CANARY SYSTEM Quantum Dental Technologies, Inc. NBL Class II 2012-10-26
K122972 CDC ZIRCONIA BLANKS Continental Dental Ceramics, Inc. (Dba Continental EIH Class II 2012-10-24
K121980 ZIRPRIME Kuraray Noritake Dental, Inc. EIH Class II 2012-10-19
K121709 ZFX DENTAL CAD SYSTEM Zimmer Dental, Inc. NHA Class II 2012-10-19
K120053 IPS E.MAX PRESS - ABUTMENT SOLUTIONS Ivoclar Vivadent, AG NHA Class II 2012-10-18
K121344 NU SLEEP Rh Associates, LLC LRK Class II 2012-10-17
K122348 QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW Recherches Techniques Dentaires (R.T.D.) EBI Class II 2012-10-15
K122331 CAVITY VARNISH Dentsply International, Inc. LBH Class II 2012-10-15
K121688 MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM Prismatik Dentalcraft, Inc. NHA Class II 2012-10-12
K122025 BRIGHTGLASS BRIGHTGLASS M Ktk Medical Supplies GmbH EBG Class II 2012-10-09
K121047 HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM Kj Meditech Co., Ltd. DZE Class II 2012-10-04
K122231 XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM Megagen Implant Co., Ltd. DZE Class II 2012-10-04
K120951 SMARTBUILDER SYSTEM Osstem Implant Co., Ltd. JEY Class II 2012-10-03
K113650 ORTHOFIX SCREW Bonafix Surgical and Dental Implants, LLC OAT Class II 2012-10-03
K121761 SOMNOGUARD SP SOFT Tomed Dr. Toussaint GmbH LRK Class II 2012-09-28
K121915 BRIGHT RESTORATIVE MATERIALS Dmp, Ltd. EBF Class II 2012-09-28
K121880 DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID Danville Materials, Inc. EBF Class II 2012-09-25
K121707 LEW MDI O-BALL COLLARED IMPLANT, Park Dental Research Corp. DZE Class II 2012-09-24
K121589 BIOMET MICROFIXATION FACIAL PLATING SYSTEM Biomet Microfixation JEY Class II 2012-09-21
K113282 CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO Riemser Arzeimittel AG LYC Class II 2012-09-20
K121114 TIGRAN PERIBRUSH Tigran Technologies AB ELB Class II 2012-09-17
K122569 LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR 3M Company EBF Class II 2012-09-12
K120776 ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION Biomet 3i NHA Class II 2012-09-11
K121749 VERACIA Shofu Dental Corporation ELM Class II 2012-09-07
K120875 B&W DENTAL IMPLANT SYSTEM B&W Srl DZE Class II 2012-09-07
K120792 TIXOS IMPLANT SYSTEM Leader Italia S.R.L. DZE Class II 2012-09-05
K121787 BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS BioHorizons Implant Systems, Inc. DZE Class II 2012-09-05
K113376 NEOSS PROACTIVE TAPERED IMPLANT Neoss, Ltd. DZE Class II 2012-09-05
K122155 PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH Co., Ltd. MUH Class II 2012-09-04
K113753 ZIMMER DENTAL TAPERED SCREW-VENT X Zimmer Dental, Inc. DZE Class II 2012-08-30
K121230 IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE Ivoclar Vivadent, AG EBF Class II 2012-08-29
K112967 PMMA CAD/CAM DISC Polident D.O.O., Dental Products Industry EBG Class II 2012-08-28
K120239 ELEVANCE Midmark EIA Class I 2012-08-24
K121502 SYNTHES CURVILINEAR DISTRACTION SYSTEM Synthes, Inc. MQN Class II 2012-08-23
K121824 ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 Lascod Spa ELW Class II 2012-08-23
K122240 BONE PLUS BCP EAGLE EYE Megagen Implant Co., Ltd. LYC Class II 2012-08-21
K113568 MTA-FILLAPEX Paxmed International KIF Class II 2012-08-21
K121334 VARIOECO Thommen Medical AG NHA Class II 2012-08-14
K121396 DYNAFLEX Dyna Flex NXC Class II 2012-08-14
K120152 CERASORB PLUS Riemser Arzneimittel AG NPM Class II 2012-08-13
K120847 ET/SS IMPLANT SYSTEM Osstem Implant Co., Ltd. DZE Class II 2012-08-10
K121524 INSIGNIA Ormco Corp. DYW Class II 2012-08-09
K112787 KERATOR Kj Meditech Co., Ltd. NHA Class II 2012-08-08

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