meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
33
Latest Decision
2012-02-17

Clearances · page 35 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K111935 TI-BASE ABUTMENT, 1 CONNECT ABUTMENT Nt-Trading GmbH and CO KG NHA Class II 2012-02-17
K111421 SIRONA DENTAL CAD/CAM SYSTEM Sirona Dental Systems GmbH NHA Class II 2012-02-17
K110278 CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 Nakanishi, Inc. EKX Class I 2012-02-15
K113406 AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL Dentsply International, Inc. ELW Class II 2012-02-13
K110623 PILLAR PALATAL IMPLANT SYSTEM Medtronic Xomed, Inc. LRK Class II 2012-02-10
K113426 VERACIA SA Shofu Dental Corporation ELM Class II 2012-02-08
K111249 ORTHOSLENDERIZER Orthomatics, Inc. EFB Class I 2012-02-08
K113401 ORTHO-1(NOT FINALIZED) Bisco, Inc. DYH Class II 2012-02-07
K113360 MEDICAL IMAGE PROCESSING UNIT Humanray Co,Ltd EAP Class II 2012-02-07
K112673 PROPHY-MATE NEO Nakanishi, Inc. EFB Class I 2012-02-07
K113334 AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS Opal Orthodontics by Ultradent Products, Inc. NJM Class II 2012-02-03
K112188 PIEZOTOME SOLO Satelec - Acteon, Inc. DZI Class II 2012-02-03
K112099 CONTOUR HEALER Contour Healer, LLC NHA Class II 2012-02-03
K112540 S-MINI IMPLANT SYSTEM Neobiotech Co., Ltd. DZE Class II 2012-02-03
K113197 APC FLASH-FREE ADHESIVE 3M Unitek Corporation DYH Class II 2012-02-02
K111364 HAPTITE COATING IMPLANT SYSTEM Dentis Co., Ltd. DZE Class II 2012-02-01
K112333 LRT ATTACHMENT Bcf Certification, Inc. NHA Class II 2012-01-30
K113606 NNC GOLD ABUTMENT FOR BRIDGES Straumann USA NHA Class II 2012-01-27
K112875 BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS Blue Sky Bio, LLC DZE Class II 2012-01-27
K113049 SOCKET GRAFT Steiner Laboratories LYC Class II 2012-01-27
K112045 SIMPLELINE II ABUTMENT SYSTEM Dentium Co., Ltd. NHA Class II 2012-01-26
K112044 ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A Anaxdent GmbH EBF Class II 2012-01-26
K112574 PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT Prime Dental Manufacturing, Inc. EMA Class II 2012-01-23
K113146 PCXX VARNISH Ross Healthcare, Inc. LBH Class II 2012-01-23
K113301 CONCENPIECE,HIGH-SPEED HANDPIECE SERIES Dentalez, Inc. EFB Class I 2012-01-23
K113092 ZIMMER CONTOUR PROVISIONAL COPING Zimmer Dental, Inc. NHA Class II 2012-01-23
K113645 REGENEROSS ALLOGRAFT PLUS MINERLIZED Biomet Interpore Cross NUN Class II 2012-01-20
K103697 TORQTECH J. Morita USA, Inc. EGS Class I 2012-01-20
K112716 OSTEON II Genoss Co., Ltd. LYC Class II 2012-01-17
K113497 HYPERION Cefla S.C. Cefla Dental Group MUH Class II 2012-01-17
K120011 HEISENBERG EFFECT SHADES 3M Espe AG EIH Class II 2012-01-13
K111162 SLIM ONEBODY SYSTEM Dentium Co., Ltd. DZE Class II 2012-01-13
K112707 GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM Ortho Technology, Inc. NJM Class II 2012-01-13
K113410 NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT Straumann USA NHA Class II 2012-01-13
K112730 ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION Biomet 3i NHA Class II 2012-01-13
K110888 ABSOLUTE WHITE LIGHT Dr. Fresh, Inc. EEG Class I 2012-01-12
K111761 NEO TITANIUM MESH, CTI-MEM Neobiotech Co., Ltd. JEY Class II 2012-01-10
K111623 I-ENDO DUAL Satelec - Acteon Group EBW Class I 2012-01-10
K112046 MTA ANGELUS Angelus Industria DE Productos Odontologicos KIF Class II 2012-01-06
K111103 DIGITAL X-RAY IMAGING SYSTEM Rf Co., Ltd. MUH Class II 2012-01-05
K112572 GEISTLICH COMBI-KIT COLLEGEN Geistlich Pharma AG NPM Class II 2011-12-28
K113283 NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS Straumann USA NHA Class II 2011-12-28
K113040 CERAMIR CROWN & BRIDGE Doxa Dental AB EMA Class II 2011-12-28
K112575 GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO Geistlich Pharma AG NPM Class II 2011-12-27
K111680 DR. GREENSBURG'S HYBRID Always More Marketing, Inc. LRK Class II 2011-12-23
K110198 BLUE SKY BIO TCP Blue Sky Bio, LLC LYC Class II 2011-12-22
K113444 N-HYBRIDE-COMPOSITE LC FLOW Voco GmbH EBF Class II 2011-12-21
K113563 N-HYBRIDE-COMPOSITE LC Voco GmbH EBF Class II 2011-12-21
K113251 SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES Synthes, Inc. JEY Class II 2011-12-21
K112623 AIRLIGHT DENTAL HANDPIECE Beyes Dental Canada, Inc. EFB Class I 2011-12-16
K112869 EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400 Beyes Dental Canada, Inc. EFB Class I 2011-12-16
K110881 ULTRASONIC SURGICAL UNIT Dong IL Technology , Ltd. DZI Class II 2011-12-16
K112428 NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT Novabone Products, LLC LYC Class II 2011-12-16
K102456 INTRAORAL BELSENSOR GOLD Takara Belmont USA, Inc. MUH Class II 2011-12-15
K110392 PSM LOMAS / BENEFIT SCREWS Psm Medical Solutions OAT Class II 2011-12-14
K112501 VENUS PEARL PLT REFILL A1 Heraeus Kulzer, LLC EBF Class II 2011-12-14
K112160 TAPERED SCREW-VENT X IMPLANT Zimmer Dental, Inc. DZE Class II 2011-12-14
K112946 ACTIV VARNISH Pulpdent Corporation LBH Class II 2011-12-09
K111853 ANGLED TAPERED ABUTMENT Zimmer Dental, Inc. NHA Class II 2011-12-08
K110379 AIR-N-GO Satelec EFB Class I 2011-12-08
K110926 BONE PLATE; BONE SCREW Biomaterials Korea, Inc. JEY Class II 2011-12-08
K112597 SEITY 37% PHOSPHORIC ACID ETCHANT GEL Mycone Dental Supply Co., Inc. KLE Class II 2011-12-07
K111889 ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT Zimmer Dental, Inc. DZE Class II 2011-12-06
K110615 WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE Bebe Toys Manufactory , Ltd. KKO Class II 2011-12-02
K111907 DYNAMIC DU SERIES PORTABLE DENTAL UNIT Shanghai Dynamic Industry Co., Ltd. EIA Class I 2011-12-02
K112138 ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT Astra Tech, Inc. NHA Class II 2011-12-01
K113201 NARVAL CC Resmed Sas LQZ Class II 2011-12-01
K112806 JENSEN ZIRCONIA Jensen Industries, Inc. EIH Class II 2011-12-01
K111087 FOUNDATION Olympus Terumo Biomaterials Corporation LYC Class II 2011-11-29
K110955 ANYRIDGE INTERNAL IMPLANT SYSTEM Megagen Co., Ltd. DZE Class II 2011-11-22
K112380 CLEARVISION Midmark Corp. MUH Class II 2011-11-22
K112168 COMPONEER Coltene/Whaledent AG EBF Class II 2011-11-21
K111709 FOUNDATION DENTAL RESIN Unix-Japan Co., Ltd. EBI Class II 2011-11-18
K111216 OSSEOTITE 2 DENTAL IMPLANTS Biomet 3i, Inc. DZE Class II 2011-11-18
K111290 PIEZO BONE SURGERY Guilin Woodpecker Medical Instrument Co., Ltd. DZI Class II 2011-11-18
K112118 DREAMBOND Bisco, Inc. KLE Class II 2011-11-17
K111982 CLEARFIL DC CORE PLUS Kuraray America, Inc. EBF Class II 2011-11-17
K111855 HY-BOND RESIGLASS Shofu Dental Corp. EMA Class II 2011-11-17
K110661 ACCELEDENT Orthoaccel Technologies, Inc. OYH Class II 2011-11-17
K112205 SNORERX 9.0 Consumer Health Products, Inc. LRK Class II 2011-11-16
K112640 HYPERELASTIC WIRE Ormco Corp. DZC Class I 2011-11-16
K112280 STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM Straumann USA NHA Class II 2011-11-16
K113263 ARGES IMAGING CONTRAST SPRAY Arges Imaging, Inc. ELW Class II 2011-11-14
K113279 IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT Kettenbach GmbH & Co. KG ELW Class II 2011-11-14
K111984 SPI VARIO ANGLED ABUTMENT Thommen Medical AG NHA Class II 2011-11-10
K112321 CS 1200 Carestream Health, Inc. EIA Class I 2011-11-10
K112152 CERCON HT Dentsply International, Inc. EIH Class II 2011-11-09
K112447 GRANDIO CORE DUAL CURE Voco GmbH EBF Class II 2011-11-08
K112186 FIBER DISK AND BLOCK Bioloren S.R.L. EBG Class II 2011-11-08
K103291 BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE BioHorizons Implant Systems, Inc. NHA Class II 2011-11-04
K112397 ORTHO-JET CRYSTAL Lang Dental Mfg. Co., Inc. EBI Class II 2011-11-04
K103691 BIOHORIZONS ABUTMENTS FOR ZIMMER BioHorizons Implant Systems, Inc. NHA Class II 2011-11-03
K103820 REPROBONE DENTAL GRAFTING MATERIAL Ceramisys, Ltd. LYC Class II 2011-11-03
K112259 NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS Nobel Biocare AB NHA Class II 2011-10-28
K112445 SOFRELINER TOUGH S Tokuyama Dental Corporation EBI Class II 2011-10-28
K112746 DIOSLIMON IMPLANT SYSTEM Dio Corporation DZE Class II 2011-10-21
K112374 X-TRA BASE Voco GmbH EBF Class II 2011-10-20
K112710 ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR Wieland Dental + Technik GmbH & Co. KG EIH Class II 2011-10-17
K111975 CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK Kuraray Medical, Inc. KLE Class II 2011-10-14
K111958 TETRIC EVOCERAM BULK FILL Ivoclar Vivadent, Inc. EBF Class II 2011-10-14

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