meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
37
Latest Decision
1997-09-05

Clearances · page 76 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K972951 HIPALLAUR 51 Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-09-05
K972533 VERA SOLDER Aalba Dent, Inc. EJS Class II 1997-09-05
K972953 PALAUREX 76KF Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-09-05
K972956 PALCERAM 82SF Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-09-05
K972534 ALFALLOY Aalba Dent, Inc. EJS Class II 1997-09-05
K972952 AUREBOND 51 Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-09-05
K972950 HIPALLAUR 19 Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-09-05
K972955 PALCERAM 56 Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-09-05
K972954 PALAUREX 78 Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-09-05
K972421 EASY BOND Parkell, Inc. KLE Class II 1997-08-29
K972355 3M AURORA SYSTEM 3M Company EBZ Class II 1997-08-29
K972941 AURECAST 74 Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-08-28
K972942 AURECAST 83 Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-08-28
K972939 AURECAST BIO 59PF Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-08-26
K972940 AURECAST BIO 69PF Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-08-26
K972594 METALPRIMER II GC America, Inc. KLE Class II 1997-08-26
K972240 IMTEC BIOBARRIER MEMBRANE Imtec Corp. NPK Class II 1997-08-26
K972319 AURECAST GF Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-08-26
K972444 3I INNOVATIVE IMPLANTS AND COVER SCREWS Implant Innovations, Inc. DZE Class II 1997-08-26
K972936 AURECAST 2 Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-08-25
K972023 SLEEP-IN BONE SCREW SYSTEM Influence, Inc. LRK Class II 1997-08-25
K972937 AURECAST 4 Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-08-25
K972938 AURECAST 10 Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-08-25
K972061 TOA W. Keith Thornton, D.D.S. LRK Class II 1997-08-21
K965032 THE PERIOSEAL DENTAL IMPLANT Perioseal DZE Class II 1997-08-20
K970129 TULIP Richard Ting ELW Class II 1997-08-18
K972683 V-DELTA 450 Metalor Dental USA Corp. EJS Class II 1997-08-18
K954758 ROOTFORM DENTAL IMPLANT SYSTEM Swiss Dental Center DZE Class II 1997-08-18
K972029 BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM Bicon, Inc. DZE Class II 1997-08-18
K972322 LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES Walter Lorenz Surgical, Inc. JEY Class II 1997-08-18
K972632 VERA PD SOLDER Aalba Dent, Inc. EJT Class II 1997-08-15
K972276 CEREC 2 CROWN SOFTWARE Siemens AG ELW Class II 1997-08-15
K972118 VERA PDN Aalba Dent, Inc. EJH Class II 1997-08-15
K972532 AALBA GOLD SOLDER Aalba Dent, Inc. EJT Class II 1997-08-15
K972369 SEALAPEX Sybron Dental Specialties, Inc. KIF Class II 1997-08-15
K963520 IMZ TWIN PLUS SCREW Imz, GmbH DZE Class II 1997-08-12
K972154 COHEN DISTRACTOR Howmedica Leibinger, Inc. JEY Class II 1997-08-11
K972166 GUERRERO - BELL DISTRACTOR Howmedica Leibinger, Inc. JEY Class II 1997-08-11
K963521 IMZ TWIN PLUS - CYLINDER Imz, GmbH DZE Class II 1997-08-06
K972278 CYTOPLAST REGENTEX TITANIUM 250 Osteogenics Co. LYC Class II 1997-08-06
K970812 PM 2002 CC PROLINE Planmeca Oy EHD Class II 1997-08-05
K962548 BSM BONE SUBSTITUTE MATERIAL KIT Etex Corp. LYC Class II 1997-08-05
K972239 ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING Zhermack S.P.A. ELW Class II 1997-08-01
K971589 REACH ANTIBACTERIAL TOOTHBRUSH Personal Products Co. EFW Class I 1997-07-24
K971642 DENTALIS KEZ ENDODONITC SEALER Neodental Chemical Products Co., Ltd. EMA Class II 1997-07-24
K971138 DINABASE (TM) Sultan Chemists, Inc. EBI Class II 1997-07-21
K971706 TIADAPT ABUTMENT SYSTEM Nobel Biocare Uas, Inc. NHA Class II 1997-07-21
K971641 ANTIBACTERIAL GUTTA PERCHA Dr. Howard Martin, P.A. EKM Class I 1997-07-21
K972131 BREATH ACE BREATHFRESHENER Beyond 21st Century, Inc. LCN Class I 1997-07-18
K972027 ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) Zhermack S.P.A. ELW Class II 1997-07-16
K971002 SMILE WITH CONFIDENCE Lloyd V. Ziemendorf EHS Class II 1997-07-15
K970683 ZENTIH FLOWABLE COMPOSITE (MULTIPLE) Foremost Dental Mfg., Inc. EBF Class II 1997-07-15
K972006 ACTA OEM MODULE Interactive Consulting, Inc. EBZ Class II 1997-07-10
K972026 SP4044 & SP4055 LUX MODULES Satelec ELC Class II 1997-07-09
K972019 PEFECT SHOT International Imaging Electronics EIA Class I 1997-07-03
K971278 PURE COMPANY FLUID DELIVERY SYSTEM Pure Co. EIA Class I 1997-07-03
K970073 BIO-ESTHETIC INDIRECT ABUTMENT Steri-Oss, Inc. NHA Class II 1997-07-03
K970484 ACCU-PREP Bisco, Inc. KOJ Class II 1997-07-01
K971927 HI DENSE TC Shofu Dental Corp. EMA Class II 1997-06-30
K971578 ENDOSSEOUS DENTAL IMPLANT Straumann USA DZE Class II 1997-06-30
K972234 RCT GEL ROOT CANAL THERAPY GEL Dentsply Intl. EIC Class I 1997-06-30
K971692 OSTEOPOWER SYSTEM AND ACCESSORIES Osteomed Corp. KMW Class II 1997-06-27
K971121 ENCORE BOND Centrix, Inc. KLE Class II 1997-06-27
K971899 ENDO-SEAL Ultradent Products, Inc. KIF Class II 1997-06-26
K972047 KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE KLS-Martin L.P. MQN Class II 1997-06-24
K963546 SMF TITANIUM (TI) ALLOY BONE SCREWS Synthes (Usa) DZL Class II 1997-06-24
K971639 PLUSTRON ION TOOTHBRUSH SYSTEM Sas Group, Inc. MMD Class I 1997-06-24
K971898 PERMALUTE, TRY-IN PASTE Ultradent Products, Inc. EBF Class II 1997-06-24
K971987 SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR Synthes (Usa) JEY Class II 1997-06-24
K970127 EDOSSEOUS DENTAL IMPLANT Sulzer Calcitek, Inc. DZE Class II 1997-06-23
K970752 SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM Sulzer Calcitek, Inc. DZE Class II 1997-06-23
K972033 PLANMECA INTRACAM Planmeca Oy EIA Class I 1997-06-20
K971622 MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM Mpl Technologies, Inc. KIF Class II 1997-06-20
K971774 NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION Nsk Nakanishi, Inc. EFB Class I 1997-06-20
K964942 INFECTION CONTROL CARTRIDGE Dentalpure Corp. EIA Class I 1997-06-19
K960724 BIO-GIDE RESORBABLE BILAYER MEMBRANE Geistlich-Pharma NPK Class II 1997-06-11
K971887 BREATH TAKER Hofa, LLC LCN Class I 1997-06-10
K971603 STERILE SUREFLEX FILES AND INSTRUMENTS Dentsply Intl. EFA Class I 1997-06-04
K970339 TRI AUTO ZX J. Morita USA, Inc. EKX Class I 1997-06-04
K971350 SERIES XE, SERIES SE, SERIES TE Micro-Mega Societe Anonyme EGS Class I 1997-06-04
K970506 HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT Benlioglu Dental Ithalat, Inc. EBZ Class II 1997-06-04
K971575 BENCHMARK-IV J.F. Jelenko & Co., Inc. EJT Class II 1997-06-04
K971606 STERILE FLEXOFILE FILES AND INSTRUMENTS Dentsply Intl. EFA Class I 1997-06-03
K971063 OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR King Dental Corp. KLC Class I 1997-06-03
K970774 TEMPOCEM NE (MULTIPLE) Foremost Dental Mfg., Inc. EMA Class II 1997-06-03
K971513 COMPOGLASS F Ivoclar North America, Inc. EBF Class II 1997-06-03
K970775 TEMPO CEM (MULTIPLE) Foremost Dental Mfg., Inc. EMA Class II 1997-06-03
K971284 OPALDAM Ultradent Products, Inc. EIG Class I 1997-06-03
K971372 VARIOLINK II Ivoclar North America, Inc. EBF Class II 1997-05-29
K964802 CYBERJET LOCAL ANESTHESIA SYSTEM Intra Vantage, Inc. EGM Class II 1997-05-27
K970776 LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT Lifecore Biomedical, Inc. DZE Class II 1997-05-27
K971100 ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR Atrion Medical Products, Inc. EIA Class I 1997-05-23
K971155 MEMOREG Heraeus Kulzer, Inc. ELW Class II 1997-05-22
K971319 NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES Tycom Dental EKS Class I 1997-05-22
K971025 AYURVEDIC TONGUE CLEANER Calello Martinez P.C. LCN Class I 1997-05-22
K971574 JELBOND-PDF J.F. Jelenko & Co., Inc. EJT Class II 1997-05-20
K971292 JEL-71 PDF J.F. Jelenko & Co., Inc. EJT Class II 1997-05-20
K962753 KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS) Biomedical Implant Technology, Inc. DZE Class II 1997-05-19
K970649 HERO 642 Micro-Mega EKS Class I 1997-05-16
K970522 MYERSON'S ECONOMY DENTURE BASE MATERIAL Austenal, Inc. EBI Class II 1997-05-14

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