meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
40
Latest Decision
2004-12-17

Clearances · page 54 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K043119 AMELOGEN PLUS Ultradent Products, Inc. EBF Class II 2004-12-17
K043177 CLEAFIL DC CORE AUTOMIX Kuraray Medical, Inc. EBF Class II 2004-12-17
K042878 FLEXITIME XTREME Heraeus Kulzer, Inc. ELW Class II 2004-12-17
K043307 CRANEX D Soredex Palodex Group OY EHD Class II 2004-12-17
K042638 RADIANCE PORCELAIN Aurident, Inc. EIH Class II 2004-12-17
K043131 TORPICALGIN Zhermack S.P.A. ELW Class II 2004-12-15
K042820 SYSTEMP.C&B PLUS Ivoclar Vivadent, Inc. EBG Class II 2004-12-14
K043190 SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM Innova Life Sciences Corp. NHA Class II 2004-12-14
K040671 EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES Anthogyr EJI Class II 2004-12-14
K043092 PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 Progeny, Inc. EHD Class II 2004-12-13
K042931 TUF LINK SILICONE RELINER Dentatus USA , Ltd. EBI Class II 2004-12-08
K042452 RIVA SILVER Southern Dental Industries, Inc. EMA Class II 2004-12-07
K030052 OSTIM Heraeus Kulzer, Inc. LYC Class II 2004-12-06
K042929 ESTENIA C&B Kuraray Medical Kurashiki Plant EBF Class II 2004-12-06
K041834 ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM Takara Belmont USA, Inc. MUH Class II 2004-12-03
K042548 CERASYS - ZR Cerasys, Inc. EIH Class II 2004-12-03
K042860 CORRECT DENTAL IMPRESSION MATERIAL Handae Chemical Co., Ltd. ELW Class II 2004-12-03
K042823 COSMEDENT PIT & FISSURE SEALANT Cosmedent, Inc. EBC Class II 2004-12-01
K042828 OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 Young O/S, LLC EKR Class I 2004-12-01
K042913 CLEARFIL TRI-S BOND Kuraray Medical, Inc. KLE Class II 2004-11-26
K042466 X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE Zest Anchors, Inc. NHA Class II 2004-11-24
K042806 QUADRANT UNIT-1-BOND Cavex Holland BV KLE Class II 2004-11-24
K042769 ADSEAL ROOT CANAL SEALER Meta Biomed Co., Ltd. KIF Class II 2004-11-24
K042987 MODIFICATION TO SYNTHES CRANIAL PLATES Synthes (Usa) JEY Class II 2004-11-23
K042872 RONDOFLEX PLUS 360 Kavo America Corporation KOJ Class II 2004-11-23
K031568 BICONITE SURFACE TREATMENT Bicon, Inc. DZE Class II 2004-11-23
K033033 VIZILITE-BLUE ORAL EXAM KIT Trylon Corp. EAZ Class I 2004-11-22
K042848 FRC POSTEC PLUS Ivoclar Vivadent, Inc. ELR Class I 2004-11-22
K042614 S&C-SELF ETCH PR-BOND S & C Polymer GmbH KLE Class II 2004-11-22
K042348 GRADIA DIRECT LOFLO GC America, Inc. EBF Class II 2004-11-18
K043042 PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 Nobel Biocare AB NHA Class II 2004-11-18
K042365 SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM Synthes (Usa) JEY Class II 2004-11-18
K042637 THE 5.0 X 6.0MM DENTAL IMPLANT Bicon, Inc. DZE Class II 2004-11-15
K042197 BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION Ed. Geistlich Soehne AG Fuer Chemische Industrie NPL Class II 2004-11-15
K042422 D3 CHROMA Sybron Dental Specialties, Inc. DYH Class II 2004-11-15
K042888 DEMETRON IDS CURING LIGHT Kerr Corp. EBZ Class II 2004-11-10
K041680 ORAJEL ADVANCED TOOTH DESENSITIZER Del Pharmaceuticals, Inc. KLE Class II 2004-11-10
K042171 AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 Micro-Mega Societe Anonyme EGS Class I 2004-11-10
K042819 TETRIC EVOCERAM Ivoclar Vivadent, Inc. EBF Class II 2004-11-09
K042516 OTOMIMIX Walter Lorenz Surgical, Inc. NEA Class II 2004-11-08
K042153 SOUTH BEACH SMILE LIGHT WHITENING SYSTEM Dentovations, Inc. EEG Class I 2004-11-08
K041392 SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US CAO Group, Inc. EEG Class I 2004-11-08
K042905 NEO-CLIP ORTHODONTIC BRACKET ACCESSORY Dentsply Intl. NJM Class II 2004-11-04
K042434 MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 NOUVAG AG DZI Class II 2004-11-03
K042339 NEOPLANT IMPLANT SYSTEM Neobiotech Co., Ltd. DZE Class II 2004-11-02
K042196 SAVEDENT BLUE Denfotex Light Systems, Ltd. EBZ Class II 2004-11-01
K042670 FUTURABOND NR Voco GmbH KLE Class II 2004-11-01
K041271 STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM Sterngold DZE Class II 2004-10-28
K042161 ANTI-SNORING/SLEEP APNEA DEVICE Rj & VK Bird Pty , Ltd. LRK Class II 2004-10-27
K040170 FRIADENT PLUS DENTAL IMPLANT SYSTEMS Friadent GmbH DZE Class II 2004-10-27
K042048 GELATO PROPHYLAXIS PASTE Deepak Products, Inc. EJR Class I 2004-10-26
K042756 ENDOREZ Ultradent Products, Inc. KIF Class II 2004-10-26
K041755 CROMAX HIGH SPEED TURBINE HANDPIECE J.R. Medical Technologies, Inc. EFB Class I 2004-10-22
K041136 MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS Bio-Lok Intl., Inc. DZE Class II 2004-10-22
K042669 IONOFIL PLUS AC Voco GmbH EMA Class II 2004-10-20
K042759 OPTIMA MX Bien-Air SA Switzerland EIA Class I 2004-10-20
K042658 PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 Nobel Biocare Uas, Inc. NHA Class II 2004-10-20
K042706 OSSATURA DENTAL Isotis Orthobiologics, Inc. LYC Class II 2004-10-20
K042200 MI PASTE GC America, Inc. EJR Class I 2004-10-20
K034017 JEJE TEETHER Vibe 2000 MEF Class I 2004-10-18
K041272 DYRACT CEM PLUS CEMENT Dentsply Intl. EMA Class II 2004-10-18
K042573 KLS MARTIN DRILL-FREE MMF SCREW KLS-Martin L.P. DZL Class II 2004-10-18
K041718 KELES FACEMASK Great Lakes Orthodontics, Ltd. DZB Class II 2004-10-15
K040783 FOUNDATION Terumo Corp. LYC Class II 2004-10-13
K042736 CDX DIGITAL X-RAY IMAGING SYSTEM Cnc Imaging, Inc. MUH Class II 2004-10-13
K042703 CYBIRD LED CURING LIGHT Dxm Co., Ltd. EBZ Class II 2004-10-12
K042517 BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS Linvatec Biomaterials, Ltd. JEY Class II 2004-10-08
K042372 HDS INTRA-ORAL IMAGING SYSTEM Vatech Value Added Technology Co., Ltd. MUH Class II 2004-10-04
K041651 STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM Stryker Leibinger DZE Class II 2004-09-30
K042056 AZ ULTRASONIC SYSTEM J. Morita USA, Inc. ELC Class II 2004-09-30
K041279 IMPLANTEO IMPLANTOLOGY MOTOR Anthogyr EKX Class I 2004-09-23
K042462 AMERICAN DENTAL IMPLANT American Dental Implant Corporation DZE Class II 2004-09-21
K041805 MICROSCOPE SYSTEM Miras Mirror Imaging Solutions, Ltd. EIA Class I 2004-09-21
K042354 MODIFICATION TO: CRESCO TI IMPLANT CONCEPT Cresco TI Systems AB DZE Class II 2004-09-21
K042215 RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT Premier Dental Products Co. EMA Class II 2004-09-21
K042429 THE PRODIGY SYSTEM DENTAL IMPLANTS BioHorizons Implant Systems, Inc. DZE Class II 2004-09-16
K042289 MDI ORTHO Imtec Corp. DZE Class II 2004-09-15
K040143 MONORAIL Nats Corp. DZE Class II 2004-09-13
K040079 M.L. PRIMER Shofu Dental Corp. KLE Class II 2004-09-09
K041655 BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) Cowellmedi Co., Ltd. DZE Class II 2004-09-08
K042199 TRANSLUX POWER BLUE Heraeus Kulzer,GmbH EBZ Class II 2004-09-08
K042260 PHOT-X II, MODEL 303 Takara Belmont USA, Inc. EHD Class II 2004-09-07
K040858 ORALIEF THERAPY FOR SENSITIVE TEETH Novamin Technology, Inc. LBH Class II 2004-09-02
K042266 ACCLAIM Air Techniques, Inc. NRD Class I 2004-08-31
K041960 COMPOSITE/COMPOMER REPAIR KIT Dmg USA, Inc. KLE Class II 2004-08-30
K042178 ORTHODONTIC CERAMIC BRACKETS Dentsply Intl. NJM Class II 2004-08-30
K041120 EV APAN DIGITAL, MODEL K1VSM2000 Afp Imaging Corp. MUH Class II 2004-08-30
K041661 NOBEL BIOCARE ENDOSSEOUS IMPLANTS Nobel Biocare Uas, Inc. DZE Class II 2004-08-26
K041509 ANKYLOS DENTAL IMPLANT SYSTEM Friadent GmbH DZE Class II 2004-08-26
K041458 MARE DENTAL OPERATIVE UNIT Denimed Electronica S.H. EIA Class I 2004-08-24
K041371 BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN Novamin Technology, Inc. EJR Class I 2004-08-23
K041876 NOBELDIRECT OD IMPLANT Nobel Biocare Uas, Inc. DZE Class II 2004-08-20
K031813 OSSATURA DENTAL Isotis NV LYC Class II 2004-08-20
K041433 BRIGHT GOLD XH Ivoclar Vivadent, Inc. EJS Class II 2004-08-19
K040529 COCOON HYGIENIST Satelec EIA Class I 2004-08-19
K041887 SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS Synthes (Usa) DZL Class II 2004-08-19
K041527 AARHUS ANCHORAGE SYSTEM Medicon EG DZE Class II 2004-08-19
K042124 DENFIL Vericom Co., Ltd. EBF Class II 2004-08-13
K041492 ASTRA TECH IMPLANTS - DENTAL SYSTEM Astra Tech, Inc. DZE Class II 2004-08-09
K041831 PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR Progeny, Inc. MUH Class II 2004-08-09

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