meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
35
Latest Decision
1998-03-16

Clearances · page 74 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K974865 CSR Parkell, Inc. EBI Class II 1998-03-16
K974670 ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE Athena Technology, Inc. EFB Class I 1998-03-13
K974817 DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM Doctor'S Research Group, Inc. DZL Class II 1998-03-13
K973236 CREST TOOTHBRUSH WITH MICROSHIELD Procter & Gamble Co. EFW Class I 1998-03-11
K980195 FACEBOW Ortho Kinetics Corp. DZB Class II 1998-03-11
K974671 ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR Athena Technology, Inc. EFB Class I 1998-03-11
K973800 23:1 REDUCTION ANGLE Midwest Dental Products Corp. EGS Class I 1998-03-11
K974628 FRIALIT-2 PROTECT ABUTMENT Friatec AG DZE Class II 1998-03-11
K974160 BRUXTRAK MATERIAL Bruxcare, LLC EBI Class II 1998-03-11
K973679 AEROETCHER Parkell, Inc. KOJ Class II 1998-03-10
K980298 FLOWABLE HYBRID Cosmedent, Inc. EBD Class II 1998-03-09
K980613 PROGOLD ELECTROCOPING SYSTEM Micro Dental Laboratories EJT Class II 1998-03-09
K974465 SYNERGY Coltene/Whaledent, Inc. EBF Class II 1998-03-09
K980597 CARRARA PDF, CARRARA H, CARRARA R European Dental Imports, Inc. EJT Class II 1998-03-09
K980075 CYBERSONIC American Dentronics, Inc. LCN Class I 1998-03-04
K980374 IMPLANT SITE DILATORS BioHorizons Implant Systems, Inc. DZE Class II 1998-03-04
K974786 PREPQUICK Ultradent Products, Inc. KLE Class II 1998-03-03
K974752 IMTEC/BIOBARRIER MEMBRANE Imtec Corp. NPK Class II 1998-03-03
K974555 SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS) Synthes (Usa) JEY Class II 1998-03-03
K974856 3.25MM SIMPLER THREADED DENTAL IMPLANT Vancouver Implant Resources, Inc. DZE Class II 1998-02-27
K972775 FASTDAM Interdent, Inc. EIE Class I 1998-02-27
K974857 4.0MM SIMPLER THREADED DENTAL IMPLANT Vancouver Implant Resources, Inc. DZE Class II 1998-02-27
K973285 D/SENSE-T Centrix, Inc. KLE Class II 1998-02-25
K974554 SYNTHES RESORBABLE FIXATION SYSTEM Synthes (Usa) JEY Class II 1998-02-24
K980232 CLEARFIL DC CEMENT Kuraray Company, Ltd. EMA Class II 1998-02-24
K980051 PALFIQUE ESTELITE PASTE Tokuyama America, Inc. EBF Class II 1998-02-24
K980332 MTA MATERIAL Dentsply Intl. KIF Class II 1998-02-24
K980053 GLENROE CHAIN Glenroe Technologies ECI Class I 1998-02-24
K974727 JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METR J.B.C and Co. EBI Class II 1998-02-24
K974401 4.0MM SIMPLER ONE THREADED DENTAL IMPLANT Vancouver Implant Resources, Inc. DZE Class II 1998-02-23
K974280 ABUTMENT - COMPLETE The Implant Center of the Palm Beaches DZE Class II 1998-02-20
K974402 3.25 MM SIMPLER ONE THREADED DENTAL IMPLANT Vancouver Implant Resources, Inc. DZE Class II 1998-02-19
K974403 3.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT Vancouver Implant Resources, Inc. DZE Class II 1998-02-19
K974404 4.0MM SIMPLER ONE PUSHIN DENTAL IMPLANT Vancouver Implant Resources, Inc. DZE Class II 1998-02-19
K974398 PULPDENT CAVITY VARNISH Pulpdent Corp. LBH Class II 1998-02-18
K974487 SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 Asi Medical, Inc. EIA Class I 1998-02-18
K974542 TRUE VISION, TRUE VISION II Medical Dynamics, Inc. EIA Class I 1998-02-17
K974894 KROMATICA COLOR CHANGING ALGINATE Matech, Inc. ELW Class II 1998-02-12
K974531 SNORE-EZZER Snore - Ezzer LRK Class II 1998-02-12
K974772 UFI GEL C Voco GmbH EBI Class II 1998-02-10
K973542 MASKY Pressing DI Monticelli Rag. Stefano EBI Class II 1998-02-10
K974622 DENTAL D Micro Dental Laboratories EHP Class I 1998-02-10
K974358 FRIALIT -2 SCREW Friatec AG DZE Class II 1998-02-10
K974359 FRIALIT-2 CYLINDER Friatec AG DZE Class II 1998-02-10
K974494 RENAMEL FLOWABLE COMPOSITE Cosmedent, Inc. EBD Class II 1998-02-10
K973221 COMPOSITE 168 RESTORATIVE SYSTEM Dentsply Intl. EBF Class II 1998-02-09
K974483 NTL-FLOW Bisco, Inc. EBF Class II 1998-02-09
K973235 DYRACT AP RESTORATIVE Dentsply Intl. EBF Class II 1998-02-05
K974238 DENTAL TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. EIA Class I 1998-02-04
K974390 GLUMA ONE BOND Heraeus Kulzer, Inc. KLE Class II 1998-02-04
K973996 CLEARLINE PLUS, DENTAL WATERLINE FILTER Scitech Solutions, Inc. EIA Class I 1998-02-04
K974458 COMPOLUTE APLICAP Espe Dental-Medizin GmbH & Co.Kg. EMA Class II 1998-02-02
K974413 PERMAFLO Ultradent Products, Inc. EBF Class II 1998-02-02
K974126 IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW Imcor DZE Class II 1998-01-30
K974577 COMPOGLASS FLOW Ivoclar North America, Inc. EBF Class II 1998-01-30
K974392 LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM Biovision GmbH DZL Class II 1998-01-30
K974486 CLEARFIL LINER BOND 2V Kuraray America, Inc. KLE Class II 1998-01-29
K974282 VITALESCENCE Ultradent Products, Inc. EBF Class II 1998-01-29
K974704 HYDROGUM Zhermack S.P.A. ELW Class II 1998-01-29
K972935 SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL S.S. White Mfg., Ltd. EMA Class II 1998-01-29
K974231 POSITION PENTA, POSITION PENTA QUICK Espe GmbH & Co. Kg. ELW Class II 1998-01-29
K974283 PQ 1 Ultradent Products, Inc. KLE Class II 1998-01-29
K972642 PERIO CONTROL II Estrad B.V. EIK Class I 1998-01-26
K974150 PROCERA PREPARABLE ABUTMENT SYSTEM Nobel Biocare Uas, Inc. NHA Class II 1998-01-23
K972889 ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION) W & H Dentalwerk EBW Class I 1998-01-22
K974077 VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. J. Morita USA, Inc. EHD Class II 1998-01-20
K970572 DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET Implant Integration Systems, Inc. DZE Class II 1998-01-16
K963591 SNORING CONTROL DEVICE Kenneth Hilsen LRK Class II 1998-01-09
K973884 ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE Frantz Design, Inc. LRK Class II 1998-01-09
K974105 KERR COMPOMER Sybron Dental Specialties, Inc. EBF Class II 1998-01-09
K974204 VISTACAM OMNI AND VIASTCAM OMNI (IC) Air Techniques, Inc. EIA Class I 1998-01-08
K974369 APOLLO 9500 Ion Laser Technology EBZ Class II 1998-01-06
K972921 SANKO INTRAORAL DENTAL X-RAY Sanko X-Ray Manufacturing Co., Ltd. EHD Class II 1998-01-06
K972971 NPG + 2 Aalba Dent, Inc. EJH Class II 1998-01-05
K974140 ADHESIVE HYBRID IONOMER CEMENT Dentsply Intl. EMA Class II 1998-01-05
K973926 O BUTMENT HS IMPLANT O Co., Inc. DZE Class II 1998-01-05
K972480 3I BIORESORBABLE FIXATION TACK Implant Innovations, Inc. DZL Class II 1997-12-23
K973513 SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER Espe GmbH & Co. Kg. EBF Class II 1997-12-22
K964271 IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID Airel-West EIA Class I 1997-12-19
K972946 AURELUX 77 Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-12-19
K973876 PROPHYFLEX 2, MODEL 2012 Kavo America EFB Class I 1997-12-19
K971818 SNOREX Snorex (Nz) , Ltd. LQZ Class II 1997-12-18
K972198 DENT-TEMP ACRYLIC Health-Dent Intl., Inc. EBG Class II 1997-12-17
K974131 ALERT Jeneric/Pentron, Inc. EBF Class II 1997-12-17
K974035 CENTURY ALLOY Dentsply Intl. EJJ Class II 1997-12-17
K974014 PULPDENT DENTASTIC UNO Pulpdent Corp. EMA Class II 1997-12-17
K973961 3M DENT SYSTEM II PLUS 3M Company EMA Class II 1997-12-17
K974089 ALLOY PRIMER Kuraray America, Inc. KLE Class II 1997-12-17
K973594 GORE RESOLUT XT REGENERATIVE MATERIAL W. L. Gore & Associates, Inc. LYC Class II 1997-12-17
K973919 CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) Medental Intl. LBH Class II 1997-12-16
K973781 AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL Dentsply Intl. ELW Class II 1997-12-11
K973567 SOWELL COBALT-CHROME METAL ALLOY C.K. International Trading EJH Class II 1997-12-11
K973568 SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY C.K. International Trading EJH Class II 1997-12-11
K973569 SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY C.K. International Trading EJH Class II 1997-12-11
K973424 ENFRESH TONGUE BRUSH Enfresh Products, LLC LCN Class I 1997-12-09
K973089 FREEDOM Southern Dental Industries, Inc. EBF Class II 1997-12-08
K973091 WAVE Southern Dental Industries, Inc. EBF Class II 1997-12-08
K973566 SOWELL PATENTED NON-PRECIOUS METAL ALLOY C.K. International Trading EJH Class II 1997-12-08
K973092 STAE Southern Dental Industries, Inc. KLE Class II 1997-12-08
K973439 ENDO ANALYZER, MODEL 8005 Sybron Dental Specialties, Inc. EAT Class II 1997-12-08

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