meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
34
Latest Decision
2002-07-25

Clearances · page 61 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K021926 AUROPAL 60 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-07-25
K021892 BRIGHT GOLD Ivoclar Vivadent, Inc. EJT Class II 2002-07-25
K022119 EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE Electro Medical Systems SA EFB Class I 2002-07-25
K021322 ENDOSSOUS IMPLANTS Intra-Lock International DZE Class II 2002-07-24
K021437 SECURE SOFT Imtec Corp. EBI Class II 2002-07-19
K021844 ADMIRA PROTECT Voco GmbH EBC Class II 2002-07-19
K021524 LIGHT CURE DENTAL DAM Prime Dental Manufacturing, Inc. EIE Class I 2002-07-19
K022033 STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM Bioplate, Inc. JEY Class II 2002-07-19
K021383 ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL Agion Technologies, LLC EFW Class I 2002-07-17
K022038 SPI ONETIME DENTAL IMPLANT Paxmed International DZE Class II 2002-07-15
K021253 ULTRASONIC TIPS WITH DIAMOND COATING Sybron Endo/Analytic ELC Class II 2002-07-05
K020431 FIBIOCORE Est. Anthogyr ELR Class I 2002-07-03
K021146 D/SENSE 1-STEP Centrix, Inc. EJK Class II 2002-07-02
K021318 XIVE DENTAL IMPLANT SYSTEM Friadent GmbH DZE Class II 2002-07-02
K021797 L.E.DEMETRON Sybron Dental Specialties, Inc. EBZ Class II 2002-06-27
K021741 CRITERTION, MODEL #1067511 Sterngold EJT Class II 2002-06-26
K021684 THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. JEY Class II 2002-06-26
K021045 ERA IMPLANT Sterngold DZE Class II 2002-06-26
K012308 KAVO QUATTROCARE Kavo America EFB Class I 2002-06-26
K021733 AUTOPAL 50 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-06-26
K021613 NIVEOUS LIQUID DAM Shofu Dental Corp. EIE Class I 2002-06-20
K021298 ELEMENTS DIAGNOSTIC UNIT Sybron Endo/Analytic EAT Class II 2002-06-19
K021586 SECURE RELINE/PICKUP MATERIAL Imtec Corp. EBI Class II 2002-06-14
K020588 X-IMAGE DIGITAL X-RAY SYSTEM Escape Technology, Inc. MUH Class II 2002-06-13
K020957 ORACAM Video Dental Concepts, Inc. EIA Class I 2002-06-13
K020877 EXCELLITE TURBO LIGHT CURE UNIT Rolence Ent., Inc. EBZ Class II 2002-06-12
K020884 EXCELLITE LIGHT CURE UNIT Rolence Ent., Inc. EBZ Class II 2002-06-12
K020874 ULTRA-LITE 5 TURBO LIGHT CURE UNIT Rolence Ent., Inc. EBZ Class II 2002-06-12
K021833 MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM Blue Sky Bio DZE Class II 2002-06-10
K010952 SURGISIS GUIDED TISSUE REGENERATION MATRIX Cook Biotech, Inc. NPL Class II 2002-06-10
K021850 SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS Synthes (Usa) DZL Class II 2002-06-10
K021427 CLEARFIL SA PRIMER Kuraray Medical, Inc. KLE Class II 2002-06-07
K021378 PORTABLE HDX INTRAORAL X-RAY Dentalez Group EHD Class II 2002-06-07
K021372 VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY J. Morita USA, Inc. EAG Class II 2002-06-07
K021584 REPLACE SCALLOPED MARGIN IMPLANT SYSTEM Nobel Biocare Uas, Inc. DZE Class II 2002-06-05
K010132 KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4 SOADCO, S.L. DZE Class II 2002-06-04
K020776 MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS Coronet Group North America, LLC EFW Class I 2002-06-03
K021374 TOESCO AQUA BLUE LED LIGHT CURING DEVICE Toei Electric Co., Ltd. EBZ Class II 2002-05-30
K020646 REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 Nobel Biocare Uas, Inc. DZE Class II 2002-05-29
K020893 NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE Dennis R. Bailey, Dds LRK Class II 2002-05-28
K021121 AROMACRYL Aromacryl, LLC EBI Class II 2002-05-28
K013687 NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER Steven K. Sue LRK Class II 2002-05-28
K020774 IMAGINE H.E. PRESS DESIGN-CERAMIC Wieland Dental + Technik GmbH & Co. KG EIH Class II 2002-05-22
K021460 OCO DENTAL IMPLANT O Co., Inc. NHA Class II 2002-05-22
K021522 LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW Walter Lorenz Surgical, Inc. DZL Class II 2002-05-21
K020113 VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES Vector Research & Development EBF Class II 2002-05-17
K012496 CARBON POST J. Morita USA, Inc. ELR Class I 2002-05-17
K020514 PULPDENT GLAZE II Pulpdent Corporation KLE Class II 2002-05-16
K021382 SYNTHES (USA) AUTOMATED TACK DRIVER Synthes (Usa) JEY Class II 2002-05-16
K014235 OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES Implant Innovations, Inc. DZE Class II 2002-05-16
K021242 PORTALLOY 54 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-05-16
K021367 STERNGOLD 66, MODEL #1180230 Sterngold EJS Class II 2002-05-16
K013587 BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS Babies Best, Inc. KKO Class II 2002-05-14
K021416 AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL Dentsply Intl. ELW Class II 2002-05-13
K021126 EVERSTICK ORTHO Stick Tech , Ltd. EBI Class II 2002-05-13
K021413 AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL Dentsply Intl. ELW Class II 2002-05-10
K020617 NSI HEXED AND NON-HEXED IMPLANT SYSTEM Nsi DZE Class II 2002-05-10
K021258 GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER Germ Terminator Corporation MCF Class I 2002-05-10
K021410 AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL Dentsply Intl. ELW Class II 2002-05-08
K020720 OSSIFORM Unicare Biomedical, Inc. LYC Class II 2002-05-07
K020452 HIGH SILVER CONVENTIONAL Ab Ardent EJJ Class II 2002-05-07
K021038 GC ELITE CEMENT 100 GC America, Inc. EMA Class II 2002-05-03
K014068 ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 W&H Dentalwerk Buermoos GmbH EBW Class I 2002-05-03
K020760 STARFLOW HV Danville Materials, Inc. EBF Class II 2002-05-03
K021244 ACE HA SCREW DENTAL IMPLANT SYSTEM Ace Surgical Supply Co., Inc. DZE Class II 2002-05-03
K021245 DEGOTZEN SYNCHRO The Gotzen Group, Inc. EHD Class II 2002-05-03
K020502 SOLO ORTHO 3 Sybron Dental Specialties, Inc. DYH Class II 2002-05-01
K020648 GRIDLOCK 195 ADHESIVE Allodex Systems DYH Class II 2002-05-01
K013802 FRC POSTEC Ivoclar Vivadent, Inc. ELR Class I 2002-05-01
K020578 GC FUJI ORTHO BAND PASTE PAK GC America, Inc. DYH Class II 2002-04-26
K020347 AGC SPEZIALLEGIERUNG Wieland Edelmetalle GmbH & Co. EJT Class II 2002-04-24
K020570 SIMPLICITY Apex Dental Materials, Inc. KLE Class II 2002-04-24
K020505 SYNTHES TRANSLATING MAXILLARY DISTRACTOR Synthes (Usa) JEY Class II 2002-04-23
K020555 SONATA MICRO HYBRID COMPOSITE Pentron Laboratory Technologies EBF Class II 2002-04-22
K020499 BOND-3 ADHESIVE Jeneric/Pentron, Inc. KLE Class II 2002-04-22
K020303 XR PRIMER 2 Kerr Dental Materials Center KLE Class II 2002-04-19
K020253 4 ALL (DW286A) Ivoclar Vivadent, Inc. EJH Class II 2002-04-17
K020432 PULPDENT GLAZE Pulpdent Corporation EBF Class II 2002-04-17
K020242 EMULATE FAST SET AND EMULATE REGULAR SET Cavex Holland BV ELW Class II 2002-04-17
K020481 PULPDENT POST CEMENT Pulpdent Corporation EMA Class II 2002-04-17
K020394 APC PLUS ADHESIVE 3M Unitek DYH Class II 2002-04-12
K020287 DENTITION INTEGRATING MATERIAL Pulpdent Corporation EBC Class II 2002-04-12
K020206 INTRAORAL CAMERA ME-15 Dent Corp. Research & Development EIA Class I 2002-04-11
K020396 BIOCELLECT -PERIO Imtec Corp. LYC Class II 2002-04-10
K011524 IMMEDIATE STABILIZING DEVICE (ISD) O Co., Inc. DZE Class II 2002-04-10
K020376 AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE Advanced Healthcare , Ltd. EMA Class II 2002-04-09
K013067 FRIALOC DENTAL IMPLANT SYSTEM Friadent GmbH DZE Class II 2002-04-09
K020327 SURGIC IV IMPLANT CONTROL UNIT Nakanishi, Inc. EBW Class I 2002-04-08
K013672 BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM Azary Technologies, LLC JEY Class II 2002-04-08
K020949 APOLLO, MODEL 1124525 Sterngold EJT Class II 2002-04-04
K020946 ADPER PROMPT 3M Espe AG Dental Products KLE Class II 2002-04-04
K020267 OPTILUX CURING LIGHTS Sybron Dental Specialties, Inc. EBZ Class II 2002-03-29
K020898 D.SIGN 15 (DW286 B) Ivoclar Vivadent, Inc. EJH Class II 2002-03-29
K014289 ORTHOSS RESORBABLE BONE VOID FILLER Geistlich-Pharma LYC Class II 2002-03-28
K020342 UNIFIL FLOW GC America, Inc. EBF Class II 2002-03-28
K012849 GLASS POST J. Morita USA, Inc. ELR Class I 2002-03-27
K020269 PROCERA ALLCERAM BRIDGE MATERIAL Procera Sandvik AB EIH Class II 2002-03-27
K020256 UNICEM 3M Espe AG Dental Products EMA Class II 2002-03-25
K020091 OPTILUX 501 Kerr Corporation (Danbury) EBZ Class II 2002-03-21
K020239 TOUCH&BOND-PLUS Parkell, Inc. KLE Class II 2002-03-20

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