meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
40
Latest Decision
1997-05-14

Clearances · page 77 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K970850 SCANRITE DFS Scanrite Systems EHD Class II 1997-05-14
K964796 ODYSSEY I DENTAL WATER UNIT Germiphene Corp. EIA Class I 1997-05-14
K961631 ODONT HEX SYSTEM Odontit S.A. DZE Class II 1997-05-12
K970884 RESOLUT REGENERATIVE MATERIAL W. L. Gore & Associates, Inc. LYC Class II 1997-05-08
K971196 ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM Innova Corp. DZE Class II 1997-05-08
K970249 SIMPLEX AIRBRATOR Simplex Medical Systems, Inc. KOJ Class II 1997-05-07
K970848 SILOC SYSTEM Heraeus Kulzer, Inc. KLE Class II 1997-05-06
K970104 SANI-SHIELD Dw Industries, Inc. EFB Class I 1997-05-06
K964976 FLOSSBRUSH WITH FLUORIDE Flossbrush Interdental Cleaner and Applicator JES Class I 1997-05-06
K970500 3M SUSTEL DENTAL SYSTEM 3M Company EBF Class II 1997-04-30
K965205 TEFGEN - LS American Custom Medical, Inc. NPK Class II 1997-04-30
K970963 TARGIS ALLOY #7 Ivoclar North America, Inc. EJT Class II 1997-04-30
K970841 IMTEC/TITANIUM MESH Imtec Corp. JEY Class II 1997-04-30
K970930 BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE Cleft Palate Appliances, Inc. DYJ Class I 1997-04-23
K964596 PROSELECT 3 PERIDONTAL THERAPY SYSTEM Professional Dental Mfg., Inc. ELC Class II 1997-04-22
K970205 VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY Austenal, Inc. EJH Class II 1997-04-21
K970381 POWERED TOOTHBRUSH Emjoi Action USA, Ltd. JEQ Class I 1997-04-18
K952905 MINIMATIC VARIOUS IMPLANT SYSTEMS Minimatic, Inc. DZE Class II 1997-04-16
K970941 SLIPPERY GLASS Jeneric/Pentron, Inc. EIH Class II 1997-04-16
K970246 EDTA CAVIT Karolinski EBF Class II 1997-04-16
K970495 FOUNDATION INDIRECT COMPOSITE RESIN Sybron Dental Specialties, Inc. EBF Class II 1997-04-16
K970827 PRECISE Allan Schulman,D.D.S., M.S. EJH Class II 1997-04-16
K970953 E-TYPE SPEED REDUCER CONTRA ANGLE Nsk Nakanishi, Inc. KMW Class II 1997-04-15
K963063 SNORE TEC Marketing Technologies, Inc. LRK Class II 1997-04-14
K970911 LEE PLATE Howmedica Leibinger, Inc. JEY Class II 1997-04-11
K964867 HYBRID RESIN COMPOSITE Parkell, Inc. KLE Class II 1997-04-11
K964261 SMF STAINLESS STEEL BONE SCREWS Synthes (Usa) DZL Class II 1997-04-11
K963030 LEIBINGER IMF SCREW Howmedica Leibinger, Inc. DZE Class II 1997-04-11
K970123 DENTSPLY CAVITRON SPS SCALER SYSTEM Dentsply Intl. ELC Class II 1997-04-11
K970656 HYDROFLEX GC America, Inc. ELW Class II 1997-04-08
K970715 SYSTEM B HEAT SOURCE Sybron Dental Specialties, Inc. EAT Class II 1997-04-07
K965083 SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET S.S. White Mfg., Ltd. ELW Class II 1997-04-04
K970626 EASY CAM I.C.S. EIA Class I 1997-04-04
K970342 CAVITRON JET WITH SPS SYSTEM Dentsply Intl. ELC Class II 1997-04-04
K964038 CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG Heraeus Kulzer, Inc. KLE Class II 1997-04-02
K970116 ESG-1 ELECTROSONOGRAM (ESG-1) Myo-Tronics, Inc. NFQ Class I 1997-04-02
K970113 ULTRA-BLEND PLUS Ultradent Products, Inc. EJK Class II 1997-04-02
K970975 PROSTYLE INTRA Planmeca Oy EHD Class II 1997-04-01
K970594 KALGINATE IMPRESSION MATERIAL Teledyne Water Pik ELW Class II 1997-03-31
K963843 ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT Micro Motors, Inc. EFB Class I 1997-03-31
K964739 STERI-OSS TIODIZED SCREW Steri-Oss, Inc. DZE Class II 1997-03-31
K962370 PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE Challenge Products, Inc. EJR Class I 1997-03-31
K970433 AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL Dentsply Intl. ELW Class II 1997-03-27
K965091 TEETHMATE F-1 Kuraray Company, Ltd. EBC Class II 1997-03-27
K970068 JELENKO NO.1 (CODE NAME RD-0601) J.F. Jelenko & Co., Inc. EJT Class II 1997-03-24
K970134 THERMAPREP PLUS OVEN Tulsa Dental Products, Ltd. EKM Class I 1997-03-21
K962376 KREATIV KURING LIGHT SYSTEM Kreativ, Inc. EBF Class II 1997-03-21
K965238 T1 CONTROL HIGH SPEED DENTAL HANDPIECE Siemens AG EFA Class I 1997-03-19
K965165 CUTTERSIL COMFORT HARDENER Heraeus Kulzer, Inc. ELW Class II 1997-03-19
K965163 CUTTERSIL COMFORT Heraeus Kulzer, Inc. ELW Class II 1997-03-19
K964524 ILT ARGON HP Ion Laser Technology EBZ Class II 1997-03-18
K965203 RADX SYSTEM Electro Medical Systems, Inc. EHD Class II 1997-03-17
K965077 SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS Implant Innovations, Inc. DZE Class II 1997-03-17
K970114 ULTRACAL XS Ultradent Products, Inc. EJK Class II 1997-03-14
K970042 OOLI-U(TONGUE SCRAPER) Telefax Intl. LCN Class I 1997-03-14
K965082 SOOTHING WATER-FILLED TEETHER Consolidated Stores Corp. KKO Class II 1997-03-11
K964342 CYTOPLAST GBR Osteogenics Co. LYC Class II 1997-03-11
K970256 INTRAORAL MANDIBULAR DISTRACTION DEVICE Medicon EG JEY Class II 1997-03-11
K970045 SOLARO 33 Metalor Dental USA Corp. EJS Class II 1997-03-05
K970044 AUROFLUID 22 Metalor Dental USA Corp. EJS Class II 1997-03-05
K970002 STERILE WATER PUMP Micro Motors, Inc. EIA Class I 1997-03-05
K964220 REPLACE TITANIUM IMPLANT SYSTEM Steri-Oss, Inc. DZE Class II 1997-03-05
K964046 DENTSPLY PRECISION TORQUE SYSTEM Dentsply Intl. DZE Class II 1997-03-04
K964860 MARK 20 AND MARK 25 HAND ENGINE CONTROLLER Bell Intl., Inc. EBW Class I 1997-03-03
K963522 IMZ 2000 INTERLOCK 12/3 - SCREW Imz, GmbH DZE Class II 1997-03-03
K963495 IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM Imz, GmbH DZE Class II 1997-03-03
K964863 MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN Bell Intl., Inc. EBW Class I 1997-02-28
K965216 ARGI-SATIN OR OPTI0-STAR Argen Precious Metals, Inc. ELL Class II 1997-02-27
K970168 3M QUIKPLUS SYSTEM 3M Company EBG Class II 1997-02-27
K970263 PM 2002 CC PROLINE Planmeca Oy EHD Class II 1997-02-26
K964808 SPETEMP Ultradent Products, Inc. EMA Class II 1997-02-26
K964768 THREADLOC DENTAL IMPLANT SYSTEMS Sulzer Calcitek, Inc. DZE Class II 1997-02-25
K964692 PERFECTIM J. Morita USA, Inc. ELW Class II 1997-02-25
K965135 LIFECORE CONICAL ABUTMENT Lifecore Biomedical, Inc. DZE Class II 1997-02-25
K964773 DENTEMP ONE STEP Majestic Drug Co., Inc. EMA Class II 1997-02-21
K965138 DENTINSENSE B/C Centrix, Inc. KLE Class II 1997-02-14
K963945 STERI-OSS GOLD ATTACHMENT SYSTEM Steri-Oss, Inc. DZE Class II 1997-02-11
K964981 TEMPFIL C&B Sybron Dental Specialties, Inc. EBG Class II 1997-02-10
K962576 SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM Calcitek, Inc. DZE Class II 1997-02-10
K964174 MINERAL TRIOXIDE AGGREGATE (MTA) Tulsa Dental Products, Ltd. KIF Class II 1997-02-10
K964931 WHITE CORE Bisco, Inc. EBF Class II 1997-02-10
K964656 TEFGEN GUIDED TISSUE MEMBRANE American Custom Medical, Inc. NPK Class II 1997-02-10
K964810 DERMADAM Ultradent Products, Inc. EFS Class I 1997-02-10
K964944 ROUND DENTAL BUR Steri-Oss, Inc. DZE Class II 1997-02-10
K965026 PFINGST PRESSURE PASTE Pfingst & Co., Inc. EFH Class I 1997-02-10
K964735 DENTINSENSE Centrix, Inc. KLE Class II 1997-02-05
K964691 TCB TEMPORARY CROWN AND BRIDGE MATERIAL Scican EBG Class II 1997-02-04
K965060 ULTRA-ETCH STAT Ultradent Products, Inc. EBF Class II 1997-01-31
K965072 PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT Kaycor Intl., Ltd. EHD Class II 1997-01-27
K964516 TAP Nellcor Puritan Bennett, Inc. LRK Class II 1997-01-24
K964649 VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE Howmedica Leibinger, Inc. JEY Class II 1997-01-24
K964320 TONY RISO 25/30 MULTIFUNCTION SCALER Tony Riso Co., Inc. ELC Class II 1997-01-23
K964285 TETRIC CERAM Ivoclar North America, Inc. EBF Class II 1997-01-22
K964525 PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR Dentsply Intl. KLE Class II 1997-01-22
K964619 DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) Sds Dental, Inc. EIA Class I 1997-01-22
K962999 SAFETY INJECTION SYSTEM Integritech, Inc. EJI Class II 1997-01-22
K963548 DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED Mrlb Intl., Inc. EIA Class I 1997-01-22
K964191 CALCIUM HYDROXIDE MEDICAMENT Sybron Dental Specialties, Inc. EJK Class II 1997-01-22
K964330 BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) BioHorizons Implant Systems, Inc. DZE Class II 1997-01-17
K961275 SIRIUS 10, 10L, 40, 40L Micro-Mega Societe Anonyme EFB Class I 1997-01-17

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