meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
30
Latest Decision
2011-04-21

Clearances · page 37 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K103194 INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM Intra-Lock International, Inc. DZE Class II 2011-04-21
K101827 OSTEOSCAF Texas Innovative Medical Devices (Dba) Skeletal LYC Class II 2011-04-20
K110768 COMPUTED DENTAL RADIOGRAPHY Schick Technologies, Inc. MUH Class II 2011-04-20
K102804 SPI TITANIUM BASE FOR CAD/CAM Thommen Medical AG NHA Class II 2011-04-20
K102034 BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio, LLC DZE Class II 2011-04-19
K110259 ARCHITEX SPACE MAINTENANCE SYSTEM Medtronic Sofamor Danek USA, Inc. JEY Class II 2011-04-13
K101201 STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064, Kat Implants, LLC DZE Class II 2011-04-13
K103556 IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) Ivoclar Vivadent, Inc. EIH Class II 2011-04-13
K101332 AMC-20 PORTABLE DENTAL CART MODEL AMC-20 Aseptico, Inc. EIA Class I 2011-04-11
K110127 PRELUDE III TONGUE SUSPENSION SYSTEM Siesta Medical, Inc. ORY Class II 2011-04-08
K110092 TAKE 1 ADVANCED RIGID TRAY Kerr Corporation ELW Class II 2011-04-08
K103600 PORTABLE X-RAY SYSTEM Digimed Corporation EHD Class II 2011-04-08
K103759 ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT Astra Tech, Inc. NHA Class II 2011-04-08
K110173 EMS AIR-FLOW MASTER PIEZON E.M.S Electro Medical Systems S.A ELC Class II 2011-04-07
K102467 UTA AND UHA Uta NHA Class II 2011-04-07
K110178 ESTELITE COLOR Tokuyama Dental Corporation EBF Class II 2011-04-05
K110378 IMPRESSION COMPOUND Spofadental ELW Class II 2011-04-05
K100724 OSSEOTITE II MODEL XIFOSSXXX Biomet 3i, Inc. DZE Class II 2011-04-01
K103498 LAKONG ULTRASONIC SCALER Lakong Medical Device Company, Ltd. ELC Class II 2011-03-31
K103339 TDS ABUTMENT FOR FRIADENT XIVE Pou YU Biotechnology Co., Ltd. NHA Class II 2011-03-31
K110796 SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE Biomers Products, LLC DYW Class II 2011-03-31
K110058 BPA-FREE PIT AND FISSURE SEALANT Novocol Inc. Dba Septodont and Confi-Dental Produc EBC Class II 2011-03-31
K103586 IOS FASTSCAN SPRAY Ios Technnologies, Inc. ELW Class II 2011-03-30
K102521 PANTINO PRO POSITINER Somnomed, Inc. LRK Class II 2011-03-28
K102874 NEW STETIC ACRYLICS New Stetic EBI Class II 2011-03-28
K110050 FIT TEST C&B Voco GmbH ELW Class II 2011-03-28
K103105 ORTHODONTIC SCREW Osstem Implant Co., Ltd. OAT Class II 2011-03-25
K102640 VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS Vertex-Dental B.V. EBI Class II 2011-03-25
K102241 ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT Anthogyr Sas EBW Class I 2011-03-23
K102635 APOLONIA LASER IMPLANT SYSTEM Csm Implant Co., Ltd. DZE Class II 2011-03-22
K103136 SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE Materialise NV JEY Class II 2011-03-18
K103579 INTRA SKAN DC Skanray Technologies EHD Class II 2011-03-18
K103689 PLANMECA PROMAX 3D MID Planmeca Oy MUH Class II 2011-03-17
K110371 ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY Panoramic Corp. MUH Class II 2011-03-17
K103773 ZENOFLEX DIMENSION Wieland Dental + Technik GmbH & Co. KG EIH Class II 2011-03-16
K103114 OSSPRAY SYLC CR Osspray, Ltd. EJR Class I 2011-03-14
K101913 ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM Anthogyr Sas DZE Class II 2011-03-11
K102821 DISCOVRED Phoenix Dental, Inc. LFC Class II 2011-03-11
K101607 BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS Biomet 3i, Inc. NHA Class II 2011-03-11
K101608 BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS Biomet 3i, Inc. NHA Class II 2011-03-11
K103537 ET III SA ULTRA WIDE SYSTEM Hiossen, Inc. DZE Class II 2011-03-10
K103709 CERACELL DENTAL Curasan AG LYC Class II 2011-03-10
K103585 BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP Harry J. Bosworth Co. EMA Class II 2011-03-04
K103399 GENERAL DENISTRY MOTOR Aseptico, Inc. EKX Class I 2011-02-28
K103528 IPS EMPRESS DIRECT FLOW Ivoclar Vivadent, Inc. EBF Class II 2011-02-25
K110428 ESCOM 100 Spident Co., Ltd. EBF Class II 2011-02-25
K102223 CHALLENGE-EVER Hallim Dentech Co., Ltd. EIA Class I 2011-02-25
K103004 SNORE GUARD Ranir, LLC LRK Class II 2011-02-25
K103280 BHDENTAL IMPLANT SYSTEM Bhdental, Ltd. NHA Class II 2011-02-24
K101732 ASTRA TECH IMPLANT SYSTEM Astra Tech AB DZE Class II 2011-02-23
K103076 DYNAFLEX Dyna Flex LRK Class II 2011-02-23
K102769 NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE Jjgc Industria E Comercio DE Materiais Dentarios S OAT Class II 2011-02-23
K102776 EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM Deltamed GmbH EBG Class II 2011-02-18
K103391 IVOBASE HYBRID, IVOBASE HIGH IMPACT Ivoclar Vivadent, Inc. EBI Class II 2011-02-17
K110160 BEL-CYPHER N Takara Belmont Corporation MUH Class II 2011-02-17
K102803 CLARITY ADVANCED CERAMIC BRACKETS 3M Unitek Corporation NJM Class II 2011-02-17
K103494 ZENOSTAR MAGIC GLAZE Wieland Dental + Technik GmbH & Co. KG EIH Class II 2011-02-16
K103084 NEODENT GRAFT SCREW Jjgc Industria E Comercio DE Materiais Dentarios S DZL Class II 2011-02-14
K103379 TELIO CS INLAY & TELIO CS ONLAY Ivoclar Vivadent, Inc. EBG Class II 2011-02-14
K103346 DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY Sherpa Korea ELW Class II 2011-02-11
K101902 J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 Jeil Medical Corporation DZL Class II 2011-02-08
K103474 ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) Micerium S.P.A. EBG Class II 2011-02-07
K103158 STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER Angstrom Mfg., Inc. EGS Class I 2011-02-07
K102753 TURBO TEMP 3 Danville Materials, Inc. EBG Class II 2011-02-04
K103020 ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT Atlantis Components, Inc. NHA Class II 2011-02-03
K102053 BUTLER CALCI-FLOR PROPHYLAXIS PASTE Sunstar Americas, Inc. EJR Class I 2011-02-03
K101890 BALL ABUTMENT SYSTEM Megagen Co., Ltd. NHA Class II 2011-02-03
K103190 PROFIL COMPOSITES (PROFIL, PROFIL FLOW) Silmet , Ltd. EBF Class II 2011-02-02
K102621 SOLSTICE Kerr Corporation EBZ Class II 2011-01-28
K092025 FLUID FILLED TEETHER - GEL Kids II KKO Class II 2011-01-27
K101945 NEODENT IMPLANT SYSTEM Jjgc Industria E Comercio DE Materiais Dentarios S DZE Class II 2011-01-26
K103778 LEFORTE NEURO SYSTEM BONE PLATE Jeil Medical Corporation JEY Class II 2011-01-26
K100794 FLUORCANASITE DENTAL CERAMIC Dr Sarah Pollington EIH Class II 2011-01-25
K102561 ORTHODONTIC CERAMIC BRACKET Ht Co., Ltd. NJM Class II 2011-01-25
K101225 PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1 Promimic AB DZE Class II 2011-01-25
K102218 COMPACT PIEZO P2K, POWERCARE Mectron S.P.A. ELC Class II 2011-01-24
K103157 DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE Angstrom Mfg., Inc. EGS Class I 2011-01-24
K110131 LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE 3M Espe Dental Products EBF Class II 2011-01-21
K103580 GRANDIO SO FLOW Voco GmbH EBF Class II 2011-01-21
K103351 DMC COMPOSITE 2 Kerr Corporation EBF Class II 2011-01-20
K102836 BONASIL A+ IMPRESSION MATERIALS Dmp, Ltd. ELW Class II 2011-01-13
K102872 OSBONE DENTAL Curasan AG LYC Class II 2011-01-12
K103252 CAMLOG VARIO SR ABUTMENTS Altatec GmbH NHA Class II 2011-01-10
K102822 IMPLANT-ONE SYSTEM Custom Dental Implants, Inc. DZE Class II 2011-01-10
K102184 MEDPOR CONTAIN CAN IMPLANT Porex Surgical, Inc. NPK Class II 2011-01-07
K103160 NUPRO MODEL 13016901 CAO Group, Inc. LBH Class II 2011-01-06
K102703 BUILD-IT TOTAL CORE Pentron Clinical EBF Class II 2011-01-05
K093595 CERAROOT IMPLANT SYSTEM Oral Iceberg S.L. DZE Class II 2011-01-04
K103550 YOBOSHI DENTAL UNIT Fosham Yoboshi Medical Equipment Co., Ltd. EIA Class I 2011-01-04
K100993 INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS Prismatik Dentalcraft, Inc. NHA Class II 2010-12-28
K100932 INCLUSIVE MINI IMPLANT Prismatik Dentalcraft, Inc. DZE Class II 2010-12-27
K102808 MI VARNISH GC America, Inc. LBH Class II 2010-12-22
K100883 CARRIGEN Etex Corp. LYC Class II 2010-12-21
K102770 FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW Heraeus Kulzer, LLC ELW Class II 2010-12-21
K102656 SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM Synthes (Usa) JEY Class II 2010-12-20
K103179 PRELUDE II TOUNGE SUSPENSION SYSTEM Siesta Medical, Inc. ORY Class II 2010-12-20
K102981 ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM Ace Surgical Supply Company, Inc. DZE Class II 2010-12-20
K100850 COWELL IMPLANT SYSTEM Cowellmedi Co., Ltd. DZE Class II 2010-12-20
K102641 MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE Neoortho Produtos Ortopedicos S/A JEY Class II 2010-12-20
K102341 VIPI BLOCK Vipi Industria,Comercio,Exportacao E Importacao DE EBG Class II 2010-12-16

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