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Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
41
Latest Decision
2003-08-22

Clearances · page 58 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K032448 ALTATEC CERAMIC ABUTMENT Altatec Biotechnologies NHA Class II 2003-08-22
K012681 ANKYLOS Dentsply Ceramco DZE Class II 2003-08-22
K031204 DENTAPORT ZX J. Morita USA, Inc. EKX Class I 2003-08-21
K031420 S & C -BRACKET ADHESIVES S & C Polymer GmbH DYH Class II 2003-08-20
K031584 SIROTORQUE L Sirona Dental Systems GmbH EBW Class I 2003-08-19
K032158 XIVE DENTAL IMPLANT SYSTEM MULTIPLE Friadent GmbH DZE Class II 2003-08-14
K031674 MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM Friadent GmbH DZE Class II 2003-08-14
K032284 XIVE TG DENTAL IMPLANT SYSTEM Friadent GmbH DZE Class II 2003-08-14
K030639 XIVE 3.0 DENTAL IMPLANT SYSTEM Friandent GmbH DZE Class II 2003-08-12
K031106 IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX Imtec Corp. DZE Class II 2003-08-12
K032001 POLY Q (GARANT L, PENTA M, PENTA H) 3M Espe AG Dental Products ELW Class II 2003-08-11
K032117 STRYKER TOTAL PERFORMANCE (TPS) SYSTEM Stryker Instruments DZI Class II 2003-08-08
K032152 BENCO ADMIX Southern Dental Industries, Inc. EJJ Class II 2003-08-06
K031915 PULPDENT ETCH-RITE ROYALE Pulpdent Corporation KLE Class II 2003-08-05
K031752 COLTOSOL F Coltene/Whaledent, Inc. EMA Class II 2003-08-05
K031461 CARRIER TIPS Dentsply Intl. ELC Class II 2003-08-05
K031877 EMBRACE WET-BOND RESTORATIVE MATERIAL Pulpdent Corporation EBF Class II 2003-08-01
K031851 DENTISEPTIC HPC Bethel, Inc. EFB Class I 2003-08-01
K031448 RSV (RADIOLOGY SYSTEM VISIODENT Visiodent SA EHD Class II 2003-07-31
K031658 BENCO SPHERICAL Southern Dental Industries, Inc. EJJ Class II 2003-07-29
K031475 OSSEOTITE NT CERTAIN IMPLANTS Implant Innovations, Inc. DZE Class II 2003-07-28
K031345 NOBEL DIRECT, MODELS 30937, 30938 Nobel Biocare Uas, Inc. DZE Class II 2003-07-24
K032081 KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 Kavo America EIH Class II 2003-07-24
K031615 SLED CURING LIGHT SYSTEM Dentsply International EBZ Class II 2003-07-21
K031802 CORIX 70 PLUS-USV Coramex, S.A. EHD Class II 2003-07-21
K030634 ENDOS DC Villa Sistemi Medicali S.P.A. EHD Class II 2003-07-21
K031467 GLASIONOMER FX-II Shofu Dental Corp. EMA Class II 2003-07-17
K031145 ESTYLUS ELECTRIC MOTOR SYSTEM Dentsply Intl. EFB Class I 2003-07-15
K031207 SAFETY RELEASE ARCH BAR KIT Casey Surgical, LLC DYX Class II 2003-07-15
K024343 BUTLER GUM PROPHY PASTE WITH NOVAMIN Usbiomaterials Corp. EJR Class I 2003-07-11
K031212 TEMPORARY RESIN CEMENT Parkell, Inc. EMA Class II 2003-07-11
K031868 PROPHYPEARLS Kavo America EFB Class I 2003-07-09
K023836 THE SUAD DEVICE Strong Dental, Inc. LRK Class II 2003-07-08
K031118 INTRAOS 70 Blue X Imaging Srl EHD Class II 2003-07-08
K031055 ITI DENTAL IMPLANT SYSTEM Straumann USA DZE Class II 2003-07-07
K031484 STAND OUT Kerr Corp. ELW Class II 2003-07-03
K031070 CARBON FIBER BRIDGE, MODEL 28757 Nobel Biocare AB EBI Class II 2003-07-03
K031476 FILL-IN Sybron Dental Specialties, Inc. EBG Class II 2003-07-02
K031444 OPTIBOND FL Kerr Dental Materials Center KLE Class II 2003-07-02
K031807 SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS Synthes (Usa) DZL Class II 2003-07-02
K031719 ESTHETIC ZIRCONIA ABUTMENT Nobel Biocare AB NHA Class II 2003-07-02
K031747 SPI DENTAL IMPLANT ABUTMENTS Thommen Medical AG NHA Class II 2003-07-02
K031540 APEX ELECTRIC HANDPIECE SYSTEM Lares Research, Inc. EKX Class I 2003-06-30
K030605 RAPID IMF Zygomatics , Ltd. DYX Class II 2003-06-27
K030682 CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3 Bioform, Inc. LYC Class II 2003-06-27
K023367 DETECTAR, MODEL N123-MI Neks Technologies EJB Class I 2003-06-25
K031010 MIRACLE 98 Sb Lucius, Inc. EJT Class II 2003-06-25
K030916 UFI GEL HARD C Voco GmbH EBI Class II 2003-06-19
K023815 C-1805M Anodia Systems EIA Class I 2003-06-19
K023896 C-1890 Anodia Systems EIA Class I 2003-06-19
K031696 LORENZE EXTERNAL MANDIBULAR DISTRACTOR Walter Lorenz Surgical, Inc. MQN Class II 2003-06-17
K031326 IMAGINE REFLEX Wieland Dental + Technik GmbH & Co. KG EIH Class II 2003-06-17
K030844 FINAL VARNISH LC Voco GmbH KLE Class II 2003-06-13
K031264 PORTA PRESSOVER Wieland Dental + Technik GmbH & Co. KG EJT Class II 2003-06-12
K031627 NANO-TICROWN Nano-Write Corp. EJH Class II 2003-06-11
K030641 CONTEC LIGHT Dentaurum EBZ Class II 2003-06-10
K030811 COOL CURE Samm, Inc. EBZ Class II 2003-06-10
K024111 ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED Astra Tech, Inc. DZE Class II 2003-06-10
K030807 CARIES INDICATOR Confi-Dental Products Co. LFC Class II 2003-06-09
K030951 TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P Bisco, Inc. EBF Class II 2003-06-06
K030727 POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT Healex Products, Inc. EMA Class II 2003-06-05
K030915 GRANDIO Voco GmbH EBF Class II 2003-05-30
K031543 STARCAST DENTAL ALLOYS Star Refining Precious Metals South Africa EJT Class II 2003-05-30
K030914 REBILDA DC Voco GmbH EBF Class II 2003-05-30
K030663 TOKUYAMA SOFRELINER TOUGH Tokuyama Dental Corporation EBI Class II 2003-05-29
K030699 VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC J. Morita Mfg. Corp. EAG Class II 2003-05-29
K023662 PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER Hwadong International Company , Ltd. MCF Class I 2003-05-28
K030820 EVERSTICK POST Stick Tech , Ltd. ELR Class I 2003-05-20
K030448 OSTEOMED 2.0 LOCKING PLATES AND SCREWS Osteomed LP JEY Class II 2003-05-09
K030776 MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL Discus Dental, Inc. ELW Class II 2003-05-09
K030743 ETCHANT 40% Confi-Dental Products Co. KLE Class II 2003-05-09
K030588 ARTEGRAL AND POLYSTAR SELECTION Merz Dental GmbH ELM Class II 2003-05-07
K030632 PD CASTA-H Mountain Medico, Inc. EJH Class II 2003-05-07
K030646 BELLEGLASS POINT 4 Kerr Dental Materials Center EBD Class II 2003-05-06
K031291 CDR PANX, MODEL 4792 Schick Technologies, Inc. MUH Class II 2003-05-05
K030607 KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES Kavo America EIH Class II 2003-05-02
K030488 FLUORILAQ Pascal Co., Inc. LBH Class II 2003-05-02
K023672 X O ODONTOSURGE 4 Xo Care A/S EKZ Class II 2003-04-29
K030133 SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE Dentalez Group EBF Class II 2003-04-29
K031028 THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. JEY Class II 2003-04-28
K030585 SCULPTING RESIN Bisco, Inc. EBD Class II 2003-04-28
K030568 RADII Southern Dental Industries, Inc. EBZ Class II 2003-04-24
K030243 ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 Imtec Corp. DZE Class II 2003-04-23
K030516 RIVA-SELF CURE Southern Dental Industries, Inc. EMA Class II 2003-04-17
K024285 A/T X-RAY 70 Air Techniques, Inc. EHD Class II 2003-04-16
K030435 BIOUNIVERSAL PKF Ivoclar Vivadent, Inc. EJT Class II 2003-04-15
K030292 GROMAN PREPMASTER Groman, Inc. KOJ Class II 2003-04-15
K030436 BIO UNIVERSAL Ivoclar Vivadent, Inc. EJT Class II 2003-04-15
K030416 CERACAST-V Mountain Medico, Inc. EJH Class II 2003-04-14
K030603 PROANGLE DISPOSABLE PROPHY ANGLE Pac-Dent International (Suzhou), Ltd. EGS Class I 2003-04-14
K030072 EVERSTICK PERIO Stick Tech , Ltd. EBI Class II 2003-04-10
K030414 GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL Sultan Chemists, Inc. ELW Class II 2003-04-09
K030806 BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. JEY Class II 2003-04-08
K030069 SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM Synthes (Usa) JEY Class II 2003-04-08
K023818 FIBERFILL AGP Pentron Clinical Technologies KIF Class II 2003-04-03
K030318 P2 POLYETHER Heraeus Kulzer, Inc. ELW Class II 2003-04-03
K030007 ITI DENTAL IMPLANT SYSTEM Straumann USA DZE Class II 2003-03-31
K030859 NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN Enamelite, LLC EIH Class II 2003-03-27
K030689 SPI ELEMENT DENTAL IMPLANT O 3.5 MM Thommen Medical AG DZE Class II 2003-03-26
K023998 THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE Therics, Inc. LYC Class II 2003-03-26

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