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Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
33
Latest Decision
2003-03-26

Clearances · page 59 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K023513 LOGOS JUNIOR DENTAL CHAIR AND UNIT Castellini S.P.A. EIA Class I 2003-03-26
K030312 PORTA IMPLANT Wieland Dental + Technik GmbH & Co. KG EJT Class II 2003-03-26
K023819 FIBERFILL SGP Pentron Clinical Technologies EKM Class I 2003-03-26
K024356 CLEARFIL SILANE KIT Kuraray Medical, Inc. KLE Class II 2003-03-26
K024287 FIXOBRIDGE 3-CEMENT Advanced Healthcare , Ltd. EMA Class II 2003-03-21
K030168 AGC CEM Wieland Dental + Technik GmbH & Co. KG EMA Class II 2003-03-21
K024282 ACRYLIC Inovativ, LLC EBG Class II 2003-03-21
K030647 EVA DIGITAL DENTAL X-RAY SYSTEM Afp Imaging Corp. EHD Class II 2003-03-20
K030161 SUPERBOND American Dent-All, Inc. EJH Class II 2003-03-17
K030036 TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT Pulpdent Corporation DYH Class II 2003-03-12
K024214 KAVO EVEREST TITANBLANK Kavo America EJH Class II 2003-03-12
K030185 ENDOS AC/ACP Villa Sistemi Medicali S.P.A. EHD Class II 2003-03-11
K024135 AIGIS-PLUS Sb Lucius, Inc. EJT Class II 2003-03-10
K024142 AIGIS-SUPER Sb Lucius, Inc. EJT Class II 2003-03-10
K024143 AIGIS-FINE Sb Lucius, Inc. EJT Class II 2003-03-10
K024136 AIGIS-SOFT Sb Lucius, Inc. EJT Class II 2003-03-10
K024374 RMO PLASMA CURING LIGHT Lokki Lasers Medicaux EBZ Class II 2003-03-10
K024145 AIGIS-XO Sb Lucius, Inc. EJT Class II 2003-03-07
K024139 AIGIS-INLAY Sb Lucius, Inc. EJT Class II 2003-03-07
K024144 AIGIS-PT Sb Lucius, Inc. EJT Class II 2003-03-07
K024140 AIGIS-A Sb Lucius, Inc. EJT Class II 2003-03-06
K024141 NEO 76 Sb Lucius, Inc. EJT Class II 2003-03-06
K023888 CIMOFLUOR Global Dental Products, Inc. EMA Class II 2003-03-05
K030163 ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 Aseptico, Inc. EKX Class I 2003-03-03
K024004 XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM Friadent GmbH DZE Class II 2003-03-03
K030463 MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. DZE Class II 2003-02-26
K024044 SABER TECH IMPLANTS SYSTEM Imtec Corp. DZE Class II 2003-02-21
K030354 BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER Bisco, Inc. EBD Class II 2003-02-19
K022891 THE BREATHE EZ ANTI-SNORING DEVICE D&S Redhage LRK Class II 2003-02-19
K023953 ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE St. George Technology, Inc. EGS Class I 2003-02-14
K024094 4 SEASONS Ivoclar Vivadent, Inc. EBF Class II 2003-02-14
K023842 CLEARFIL SE BOND PLUS Kuraray Medical, Inc. KLE Class II 2003-02-11
K030257 NOBEL PERFECT IMPLANT SYSTEM Nobel Biocare Uas, Inc. DZE Class II 2003-02-10
K030111 DIAMONDCOAT ULTRASONIC INSERTS Dentsply International ELC Class II 2003-02-07
K024046 TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P Bisco, Inc. EBD Class II 2003-02-06
K022959 SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 MDC Research , Ltd. EJI Class II 2003-02-05
K023799 FRIOS ALGIPORE Friadent GmbH LYC Class II 2003-02-05
K014001 DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 Oral Osteodistraction, L.P. MQN Class II 2003-02-04
K022803 WATERLASE FOR APICOECTOMY Biolase Technology, Inc. MXF Class II 2003-02-03
K023981 AHL GENERIC GLASS IONOMER LUTING CEMENT Advanced Healthcare , Ltd. EMA Class II 2003-01-31
K023814 GRADIA DIRECT GC America, Inc. EBF Class II 2003-01-30
K023976 ACROSEAL ROOT CANAL OR APICAL SEALER Septodont S.A.S. KIF Class II 2003-01-30
K030206 APEX 90 We Dong Myung Dental Industrial Co., Ltd. EJT Class II 2003-01-29
K023705 BICON TRANSITIONAL IMPLANT (BTI) SYSTEM Bicon, Inc. DZE Class II 2003-01-29
K012423 MUCOGRAFT Ed. Geistlich Soehne AG Fuer Chemische Industrie NPL Class II 2003-01-24
K023831 UCP DENTAL MATERIAL Precious Chemicals U.S.A., Inc. EJT Class II 2003-01-24
K023776 XENO III DENTAL ADHESIVE Dentsply Intl. KLE Class II 2003-01-23
K023751 EXAJET GC America, Inc. ELW Class II 2003-01-22
K023790 UCC DENTAL MATERIAL Precious Chemicals U.S.A., Inc. EJT Class II 2003-01-21
K023742 SCULPTURE PLUS NANO-HYBRID COMPOSITE Pentron Laboratory Technologies EBF Class II 2003-01-17
K023580 STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM Sterngold DZE Class II 2003-01-17
K023748 FLASH-LITE II LED DENTAL CURING LIGHT Discus Dental, Inc. EBZ Class II 2003-01-17
K023649 VITIQUE SYSTEM Dmg USA, Inc. EMA Class II 2003-01-17
K022035 OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB Osteomedics, Inc. JEY Class II 2003-01-17
K023952 REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE Nobel Biocare Uas, Inc. DZE Class II 2003-01-16
K023213 RDH-2000 Anodia Systems EIA Class I 2003-01-16
K023727 TEMPORARY CEMENT-DC010002 GC America, Inc. EMA Class II 2003-01-16
K023499 GOLD CORE PLUS Pentron Laboratory Technologies EJH Class II 2003-01-13
K023721 BONART ART-L2 LIGHT CURING UNIT Bonart Co., Ltd. EBZ Class II 2003-01-10
K023652 REMECURE MODEL CL 15E Remedent NV EBZ Class II 2003-01-09
K022844 SYNTHES RESORBABLE CONTOURABLE MESH Synthes (Usa) JEY Class II 2003-01-07
K023346 TROPHYPAN Trophy Radiologie MUH Class II 2003-01-03
K023545 ULTRA-LITE 200E LIGHT CURE UNIT Rolence Ent., Inc. EBZ Class II 2002-12-30
K010185 6.0 X 5.7MM DENTAL IMPLANT Bicon, Inc. DZE Class II 2002-12-30
K022009 3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS Implant Innovations, Inc. DZE Class II 2002-12-30
K021915 TRANSITIONAL IMPLANTS Intra-Lock International DZE Class II 2002-12-19
K024034 OCCLUFAST ROCK Zhermack S.P.A. ELW Class II 2002-12-18
K011723 ANTI-SNORING DEVICE OR ASD Pi Medical LRK Class II 2002-12-18
K024041 ZETAPLUS SOFT Zhermack S.P.A. ELW Class II 2002-12-18
K023501 GOLD CORE 35 Pentron Laboratory Technologies EJT Class II 2002-12-18
K023502 JEWEL CAST PLUS Pentron Laboratory Technologies EJH Class II 2002-12-18
K022185 UNIVERSAL CMF SYSTEM Stryker Instruments JEY Class II 2002-12-17
K023292 APEX HRI DIGITAL RADIOGRAPHY SYSTEM Krugman Technologies, Inc. MUH Class II 2002-12-13
K023477 BIOLOY Neirynck & Vogt NV EJH Class II 2002-12-13
K023466 TULIP ALGINATE IMPRESSION MATERIAL Cavex Holland BV ELW Class II 2002-12-13
K023232 SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE Smartpractice EFS Class I 2002-12-11
K023395 PORTADUR P2 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-12-11
K023391 BIOPORTA G Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-12-10
K022284 SNORE-AID MAX Dental Imagineers, LLC LRK Class II 2002-12-10
K023389 PORTA GEO TI Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-12-06
K023392 AGC SPECIAL ALLOY Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-12-06
K023810 MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. JEY Class II 2002-12-04
K023067 IMTEC SENDAX MDI ORTHO6 AND ORTHO8 Imtec Corp. DZE Class II 2002-12-03
K023035 SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER Ivoclar Vivadent, Inc. ELM Class II 2002-12-02
K023327 CYNOVAD ZIRKON Cynovad EIH Class II 2002-12-02
K022971 MICROHYBRID 11 Ab Ardent EBF Class II 2002-11-25
K023671 AQUEOUS ACRYLIC DISPERSION 28% W/W Chx Technologies, Inc. LBH Class II 2002-11-25
K022973 ADHESIVE 14 Ab Ardent KLE Class II 2002-11-22
K022975 ETCHING 15 Ab Ardent EBF Class II 2002-11-22
K022974 MICROHYBRID 12 Ab Ardent EBF Class II 2002-11-22
K022972 MICROFILL 13 Ab Ardent EBF Class II 2002-11-22
K023665 MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. JEY Class II 2002-11-22
K022821 ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E Ideatrics, Inc. DZK Class II 2002-11-15
K022900 BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES John O. Butler Co. JEQ Class I 2002-11-14
K014050 HEX-LOCK TEMPORARY ABUTMENT Sulzer Dental, Inc. DZE Class II 2002-11-13
K023645 SPI EASY DENTAL IMPLANT ABUTMENT Thommen Medical AG NHA Class II 2002-11-13
K022675 PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL Prime Dental Manufacturing, Inc. EBF Class II 2002-11-07
K023631 ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS Astra Tech, Inc. NHA Class II 2002-11-07
K023697 STERI-MATE STERILIZABLE HANDPIECE Dentsply International ELC Class II 2002-11-06
K023197 CERANUM 82 Sb Lucius, Inc. EJT Class II 2002-11-05

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