meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
35
Latest Decision
2002-11-04

Clearances · page 60 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K023200 CERANUM 76 Sb Lucius, Inc. EJT Class II 2002-11-04
K023199 CERANUM 50 Sb Lucius, Inc. EJT Class II 2002-11-04
K023198 CERANUM 90 Sb Lucius, Inc. EJT Class II 2002-11-01
K022012 SYNTHES LOW PROFILE NEURO SYSTEM Synthes (Usa) JEY Class II 2002-11-01
K023196 LUCIUS 76 Sb Lucius, Inc. EJT Class II 2002-11-01
K022663 KERADEC Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-10-31
K023486 OSSTAPLE, MAXILLOFACIAL Biomedical Enterprises, Inc. JEY Class II 2002-10-31
K023488 OSSTAPLE, CRANIOFACIAL Biomedical Enterprises, Inc. JEY Class II 2002-10-31
K023079 NEW OUTLINE Anaxdent GmbH EBG Class II 2002-10-30
K022612 IBOND GLUMA INSIDE Heraeus Kulzer, Inc. KLE Class II 2002-10-28
K023042 PQ1 Ultradent Products, Inc. KLE Class II 2002-10-28
K022653 ELITE MONOPHASE Zhermack S.P.A. ELW Class II 2002-10-28
K023002 CLEARFIL AP-X PLT Kuraray Medical, Inc. EBF Class II 2002-10-25
K022217 AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM Aseptico, Inc. EIA Class I 2002-10-24
K021250 MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) Handpiece Unlimited EBF Class II 2002-10-24
K022999 CLEARFIL AP-X PLT INTRO KIT Kuraray Medical, Inc. EBF Class II 2002-10-24
K022535 MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100 Microtech EFB Class I 2002-10-22
K022969 UNIVERSAL CERAMIC SOLDER Ivoclar Vivadent, Inc. EJT Class II 2002-10-18
K022862 TRANSCURE, MODEL 2910 Kinetic Instruments, Inc. EBZ Class II 2002-10-18
K022430 ISO FUNCTIONAL GC America, Inc. ELW Class II 2002-10-18
K022492 PULPDENT SEMI-GEL ETCH Pulpdent Corporation EBF Class II 2002-10-11
K022562 VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION Nobel Biocare AB DZE Class II 2002-10-11
K022797 TWINKY STAR Voco GmbH EBF Class II 2002-10-10
K023336 OCO DENTAL IMPLANT (5.0MM DIAMETER) O Co., Inc. DZE Class II 2002-10-09
K022996 VITA IN-CERAM YZ CUBES FOR CEREC Vident EIH Class II 2002-10-09
K022630 MODIFICATION TO FOCUS Instrumentarium Corp. EHD Class II 2002-10-09
K022811 W-5 Ivoclar Vivadent, Inc. EJT Class II 2002-10-09
K022734 PULPDENT CALCIUM HYDROXIDE PREPARATION Pulpdent Corporation KIF Class II 2002-10-07
K022299 TRILUX, Z-TONE, ACRY ROCK Ruthibras Imp. Exp. Com. DE Materiais Odontologico ELM Class II 2002-10-07
K022300 ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V Dental Vipi Ltda ELM Class II 2002-10-03
K022264 CLEAN 'N' OIL Svenska Dental Instruments AB EGS Class I 2002-10-02
K022265 LIGHT TIP Svenska Dental Instruments AB EBZ Class II 2002-10-02
K022641 TOKUYAMA REBASE II Tokuyama America, Inc. EBI Class II 2002-10-02
K022953 MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM Schick Technologies, Inc. MUH Class II 2002-10-02
K023010 SNIFF POSITION PILLOWS/POPITZ PILLOWS Aeolus International Corporation MYB Class II 2002-10-01
K022424 REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 Nobel Biocare Uas, Inc. DZE Class II 2002-09-27
K021131 CHLORAPREP Centrix, Inc. LBH Class II 2002-09-26
K022522 PULPDENT PUTTY DAM Pulpdent Corporation EIE Class I 2002-09-26
K023113 REPLACE TIUNITE ENDOSSEOUS IMPLANT Nobel Biocare Uas, Inc. DZE Class II 2002-09-26
K022912 POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM Basic Dental Implant Systems, Inc. DZE Class II 2002-09-20
K022113 3I DENTAL IMPLANT ACCESSORIES Implant Innovations, Inc. DZE Class II 2002-09-19
K022252 STERNGOLD 1, MODEL 1127781 Sterngold EJS Class II 2002-09-19
K022859 ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM Straumann USA DZE Class II 2002-09-19
K022470 PORTA SOLDER 1080 W Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-09-18
K022462 BIOPORTA SOLDER 1020 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-09-18
K022224 COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM Coltene AG DYH Class II 2002-09-18
K022469 ECO E4 Wieland Dental + Technik GmbH & Co. KG EJS Class II 2002-09-18
K022468 PORTA OPTIMUM SOLDER 900 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-09-17
K022457 PORTA OPTIMUM SOLDER 710 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-09-17
K022456 PORTA IP SOLDER V-1 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-09-17
K022467 PORTA IP SOLDER V-2 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-09-17
K022459 AUROPAL SOLDER M-1 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-09-12
K022454 PORTA OP SOLDER W-2 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-09-12
K022451 AUROPAL SOLDER W-2 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-09-11
K012473 VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT Vident DZE Class II 2002-09-11
K022452 PORTA OP SOLDER M-1 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-09-11
K022408 CEREC VITABLOCKS MK2 B.B.'S Prophy Shop EIH Class II 2002-09-06
K021928 SYNTHES (USA) RESORBABLE FIXATION SYSTEM Synthes (Usa) JEY Class II 2002-09-06
K022890 MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. JEY Class II 2002-09-06
K022796 CERCON CERAM S PORCELAIN Dentsply Intl. EIH Class II 2002-09-06
K022097 THERMIQUE Parkell, Inc. EAT Class II 2002-09-06
K021948 LUCIUS 62 Lucius Metals Com. EJT Class II 2002-09-03
K022005 SYNTHES MIDFACE DISTRACTOR Synthes (Usa) JEY Class II 2002-09-03
K021083 VERACAM Lumalite, Inc. EIA Class I 2002-08-30
K021355 ENDOSSEOUS IMPLANT Branemark Integration AB DZE Class II 2002-08-30
K022795 MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. NHA Class II 2002-08-30
K022206 JENSEN GOLD FOIL Jensen Industries, Inc. EJT Class II 2002-08-29
K022032 ACETAL Inovativ, LLC EHP Class I 2002-08-29
K022790 THE AUTOTAC SYSTEM TITANIUM TACK BioHorizons Implant Systems, Inc. DZL Class II 2002-08-28
K022030 POLY-CARB Inovativ, LLC EBG Class II 2002-08-28
K013869 SR IVOCRON Ivoclar Vivadent, Inc. EBG Class II 2002-08-28
K011879 3A DENTAL IMPLANT SYSTEM Osseco Biosource, Ltd. DZE Class II 2002-08-27
K020057 PALMLIGHT CAO Group, Inc. EBZ Class II 2002-08-27
K021947 CERANUM 87 Lucius Metals Com. EJT Class II 2002-08-26
K022150 TRIONOMER Pentron Clinical Technologies EMA Class II 2002-08-21
K022184 FLASH-LITE LED DENTAL CURING LIGHT Discus Dental, Inc. EBZ Class II 2002-08-20
K021805 SEAL & PROTECT PROTECTIVE SEALANT Dentsply Intl. LBH Class II 2002-08-19
K022025 MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT Milton Hodosh, M.D. EJK Class II 2002-08-15
K021718 INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY Suni Imaging Microsystems, Inc. MUH Class II 2002-08-15
K013618 INTRAORAL MANDIBULAR DISTRACTION SYSTEM Osteomed Corp. MQN Class II 2002-08-14
K022066 REGISTRADO X-TRA Voco GmbH ELW Class II 2002-08-14
K022425 SCREWLINE Altatec Biotechnologies N.A., Inc. DZE Class II 2002-08-14
K021642 SYNTHES CRANIOFACIAL PLATES Synthes (Usa) JEY Class II 2002-08-14
K022328 EMS PIEZON MASTER 600 Electro Medical Systems SA ELC Class II 2002-08-13
K020833 BOYD DELIVERY UNIT Boyd Industries, Inc. EIA Class I 2002-08-08
K021618 OSA RIGID INTERNAL FIXATION SYSTEM Osteomed Corp. JEY Class II 2002-08-08
K021542 ADC DENTAL Agfa Corp. MUH Class II 2002-08-06
K021511 CYTOFLEX MESH Unicare Biomedical, Inc. JEY Class II 2002-08-06
K014023 BABY TEETHER, MODEL 20104 Angelina Trading, Inc. KKO Class II 2002-08-02
K022476 RELYX RMGIP 3M Company EMA Class II 2002-08-02
K021503 UNINHIBITED Bisco, Inc. EBD Class II 2002-08-01
K021971 CERALOY Neirynck & Vogt NV EJH Class II 2002-08-01
K021341 NORMED BONE TRANSPORT DISTRACTION DEVICE Osteomedics, Inc. JEY Class II 2002-08-01
K021342 NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR Osteomedics, Inc. JEY Class II 2002-08-01
K021457 FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL Pentron Corp. EBG Class II 2002-08-01
K021450 CLINPRO PROPHY POWDER 3M Espe AG Dental Products KOJ Class II 2002-08-01
K021969 CHROLOY Neirynck & Vogt NV EJH Class II 2002-07-30
K021842 ADMIRA SEAL Voco GmbH EBC Class II 2002-07-29
K021965 CHROLOY SOLDER Neirynck & Vogt NV EJH Class II 2002-07-26
K021968 CERALOY SOLDER Neirynck & Vogt NV EJH Class II 2002-07-26

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