meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
32
Latest Decision
2002-03-20

Clearances · page 62 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K011590 RESORB-X RESORBABLE PLATING SYSTEM KLS-Martin L.P. JEY Class II 2002-03-20
K014175 SULZER DENTAL CERAMIC SYSTEM-HEXLOCK Sulzer Dental, Inc. NHA Class II 2002-03-20
K014214 SULZER DENTAL CERAMIC SYSTEM-SPLINE Sulzer Dental, Inc. DZE Class II 2002-03-19
K020192 SIMIDUR S2 Wieland Dental + Technik GmbH & Co. KG EJS Class II 2002-03-15
K020194 SIMIDUR KF PLUS Wieland Dental + Technik GmbH & Co. KG EJS Class II 2002-03-15
K020645 MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. DZE Class II 2002-03-15
K014188 NEW PROPHY POWDER Dentsply Intl. KOJ Class II 2002-03-15
K013867 XIVE DENTAL IMPLANT SYSTEM Friadent GmbH DZE Class II 2002-03-15
K020178 BELLEGLASS HP MODELING GEL Kerr Dental Materials Center EBG Class II 2002-03-15
K020195 SIMIDUR S1S Wieland Dental + Technik GmbH & Co. KG EJS Class II 2002-03-15
K014138 PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT Pulpdent Corp. DYH Class II 2002-03-14
K014133 PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE Pulpdent Corp. DYH Class II 2002-03-14
K020183 PISCES PLUS (DW286 C) Ivoclar Vivadent, Inc. EJH Class II 2002-03-13
K020190 PORTADUR P 4 Wieland Dental + Technik GmbH & Co. KG EJT Class II 2002-03-13
K014263 NEWGEN/UNIVERSAL MANDIBULAR SYSTEM Stryker Instruments JEY Class II 2002-03-08
K020391 STERN MICRO ERA ATTACHMENT SYSTEM Sterngold DZE Class II 2002-03-08
K020158 NON-EUGENOL TEMPORARY CEMENT J. Morita USA, Inc. EMB Class I 2002-03-07
K014111 REBILDA SC Voco GmbH EBF Class II 2002-03-06
K001638 O-RING PROSTHETIC ATTACHMENT Titan Implants DZE Class II 2002-03-04
K020157 TEMPORARY CROWN AND BRIDGE MATERIAL J. Morita USA, Inc. EBG Class II 2002-03-04
K020137 AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON Aseptico, Inc. EGS Class I 2002-03-04
K020117 GC FUJI LINING LC PASTE PAK GC America, Inc. EMA Class II 2002-02-28
K020115 PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM Pulpdent Corp. DYH Class II 2002-02-28
K014142 UNITE BONDING ADHESIVE 3M Unitek DYH Class II 2002-02-28
K020131 VENUS UNIVERSAL LIGHT CURING COMPOSITE Heraeus Kulzer, Inc. EBF Class II 2002-02-28
K014059 PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE Pulpdent Corp. DYH Class II 2002-02-27
K014027 OPTIBOND SOLO PLUS 4 Kerr Dental Materials Center KLE Class II 2002-02-22
K020407 LORENZ BLUE DEVICE Walter Lorenz Surgical, Inc. MQN Class II 2002-02-22
K013993 NEOCALEX Stephen M Koral, Dmd EIK Class I 2002-02-22
K013543 BOND-1 C & B Jeneric/Pentron, Inc. KLE Class II 2002-02-22
K011569 BIOSORBFX O/M 2.0/2/4 SYSTEM Bionx Implants, Inc. JEY Class II 2002-02-22
K020092 TEMPHASE Kerr Dental Materials Center EBG Class II 2002-02-22
K014042 D.SIGN 84 Ivoclar Vivadent, Inc. EJS Class II 2002-02-22
K020087 SYNTHES CRANIAL PLATES Synthes (Usa) JEY Class II 2002-02-20
K013997 UNIFIL BOND GC America, Inc. KLE Class II 2002-02-20
K013970 PRIME-DENT HEMA DESENSITIZER Prime Dental Manufacturing, Inc. EBF Class II 2002-02-19
K014249 JETPOLISHER Deldent , Ltd. KOJ Class II 2002-02-19
K020080 BONART ART-E1 ELECTROSURGERY UNIT Diagnostic Data, Inc. EKZ Class II 2002-02-19
K014252 JETSTREAM Deldent , Ltd. KOJ Class II 2002-02-19
K011147 CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT) Cavitat Medical Technologies, Inc. EHD Class II 2002-02-15
K013542 DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) Jeneric/Pentron, Inc. KLE Class II 2002-02-14
K011239 GINDA GUARD Cosmedent, Inc. EBD Class II 2002-02-14
K020050 ENAMEL BONDING SYSTEM Rite-Dent Manufacturing Corp. KLE Class II 2002-02-14
K020062 XERAFIT Metalor Technologies USA EJH Class II 2002-02-14
K013908 WATERLASE MILLENNIUM Biolase Technology, Inc. MXF Class II 2002-02-12
K020009 BRACE EZE Udent, Inc. EGD Class I 2002-02-11
K020096 ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM Institut Straumann AG DZE Class II 2002-02-08
K013929 HELIOMOLAR HB TRANSLUCENT SHADES Ivoclar Vivadent, Inc. EBF Class II 2002-02-07
K014144 EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 Afp Imaging Corp. EBF Class II 2002-02-07
K013809 D.SIGN 59 Ivoclar Vivadent, Inc. EJS Class II 2002-02-07
K013891 SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT Institut Straumann AG DZE Class II 2002-02-05
K013955 VERAVIEWEPOCS, MODEL VE J. Morita USA, Inc. EHD Class II 2002-02-04
K014179 DEMETRON LC Kerr Corp. EBZ Class II 2002-02-04
K013895 TEMPFIL Sybron Dental Specialties, Inc. EBG Class II 2002-02-04
K020070 JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002 Progeny, Inc. EHD Class II 2002-02-01
K013893 SCANX Air Techniques, Inc. MUH Class II 2002-02-01
K013824 ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH Dental Manufacturing S.P.A ELM Class II 2002-01-30
K013808 SLEEPBITE Dental Imagineers, LLC LRK Class II 2002-01-30
K013690 IDENT-A100 INTRAORAL VIDEO CAMERA Confident Technology, Inc. EIA Class I 2002-01-30
K014082 D.SIGN 53, MODEL NA1012204 Ivoclar Vivadent, Inc. EJS Class II 2002-01-30
K014245 JETSONIC 2000 Deldent , Ltd. KOJ Class II 2002-01-29
K013859 RHODIA BITE REGISTRATION MATERIAL Rhodia, Inc. ELW Class II 2002-01-29
K020171 COOLBLU2 DENTAL RESIN CURING DEVICE Dental Systems.Com, Inc. EBZ Class II 2002-01-29
K013584 EXCITE SELF ETCH Ivoclar Vivadent, Inc. KLE Class II 2002-01-28
K013881 RIBBOND - TRIAXIAL Ribbond, Inc. EBI Class II 2002-01-25
K020133 MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. DZE Class II 2002-01-25
K013674 LUXATEMP/LUXATEMP SOLAR/INSTATEMP Dmg USA, Inc. EBG Class II 2002-01-24
K014238 DELSONIC 2000 Deldent , Ltd. ELC Class II 2002-01-24
K012744 INTRAORAL LENS OPTION TO SPECTROSHADE Mht Optic Research AG EIA Class I 2002-01-23
K013555 SCI-PHARM POST SECURE Scientific Pharmaceuticals, Inc. EMA Class II 2002-01-23
K013769 V-GNATHOS SUPRA Metalor Technologies USA EJT Class II 2002-01-22
K013510 POINT 4 MODIFIED Sybron Dental Specialties, Inc. EBF Class II 2002-01-18
K012511 WATERLASE MILLENNIUM Biolase Technology, Inc. MXF Class II 2002-01-18
K013494 3.75MM AND 5.0MM SPLINE TWIST IMPLANT Sulzer Dental, Inc. DZE Class II 2002-01-18
K013519 SIMPLE Bisco, Inc. KLE Class II 2002-01-17
K011839 DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C Doxa Certex AB EBF Class II 2002-01-17
K013571 MAGICFIL Dmg USA, Inc. EBF Class II 2002-01-17
K012486 OSTEOMED BIORESORBABLE FIXATION SYSTEM Osteomed Corp. DZL Class II 2002-01-16
K013609 NEXUS 2 CLEAR Sybron Dental Specialties, Inc. EMA Class II 2002-01-16
K013647 REVOLUTION FORMULA 2 Sybron Dental Specialties, Inc. EBF Class II 2002-01-16
K013500 KAVO POLYLUX II Kavo America EBZ Class II 2002-01-14
K013969 MINIBLASTER Deldent , Ltd. KOJ Class II 2002-01-10
K013383 BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM Biomedical Implant Technology, Inc. DZE Class II 2002-01-10
K013529 POINT 4 TRANSLUCENT MODIFIED Sybron Dental Specialties, Inc. EBF Class II 2002-01-09
K013506 YELLOW SPECIAL Metalor Technologies USA EJT Class II 2002-01-03
K012839 AUROPAL, ORDER-NO.: 2101 Wieland Edelmetalle GmbH & Co. EJT Class II 2001-12-31
K012514 DIGIPAN / DPI Trophy Radiologie MUH Class II 2001-12-21
K013438 FRIALIT-2 ESTHETICBASE ABUTMENT Friadent GmbH DZE Class II 2001-12-20
K013446 GLUSITE, MODEL GLU002 Glustitch, Inc. EMA Class II 2001-12-20
K013505 AUROFLUID PLUS Metalor Technologies USA EJT Class II 2001-12-19
K013798 PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM Institut Straumann AG DZE Class II 2001-12-19
K013346 GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE W. L. Gore & Associates, Inc. LYC Class II 2001-12-19
K981052 CRESCO TI IMPLANT CONCEPT Cresco TI Systems AB DZE Class II 2001-12-18
K013570 OSSEOTITE DENTAL IMPLANTS Implant Innovations, Inc. DZE Class II 2001-12-17
K013271 DXS DIGITAL X-RAY SYSTEM Douglas C. Yoon, Dds MUH Class II 2001-12-13
K013411 PULPDENT CAVITY PREPARATION IV Pulpdent Corp. LBH Class II 2001-12-12
K013400 SYNERGY FLOW Coltene/Whaledent, Inc. EBF Class II 2001-12-10
K013055 THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. JEY Class II 2001-12-07
K013659 MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM Sirona Dental Systems GmbH MUH Class II 2001-12-06
K013650 ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD Sirona Dental Systems GmbH MUH Class II 2001-12-06

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