meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
32
Latest Decision
1997-01-17

Clearances · page 78 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K964772 AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS) Ivoclar North America, Inc. EJT Class II 1997-01-17
K964430 PULPDENT SNOOP Pulpdent Corp. LFC Class II 1997-01-17
K964949 AURORA 53 Gateway Alloys, Inc. EJT Class II 1997-01-13
K964950 LA PLATA 28 (PM-28) Gateway Alloys, Inc. EJT Class II 1997-01-13
K964948 AURORA 52 (PM-01) Gateway Alloys, Inc. EJT Class II 1997-01-13
K964941 EL DORADO 40 Gateway Alloys, Inc. EJT Class II 1997-01-13
K964940 TAOS 28 Gateway Alloys, Inc. EJT Class II 1997-01-13
K964133 AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE American Dental Products, Inc. KLE Class II 1997-01-09
K964179 SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS S.S. White Mfg., Ltd. EBF Class II 1997-01-09
K961235 SIRIUS 180, 180L, 230, 230L Micro-Mega Societe Anonyme EFB Class I 1997-01-08
K964192 ARDENT NON GAMMA-2 70 Ardent Production Development EJJ Class II 1997-01-06
K963403 ACURAY DIGITAL X-RAY New Image Industries, Inc. EHD Class II 1997-01-02
K964809 SPETEMP EF Ultradent Products, Inc. EMA Class II 1997-01-02
K964145 ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 Crystal Mark, Inc. KOJ Class II 1996-12-31
K963951 AS 123 PROSTHETIC INSTRUMENTATION SYSTEM BioHorizons Implant Systems, Inc. DZE Class II 1996-12-31
K964177 KROMALGIN IMPRESSION MATERIAL North American Orthodontic Laboratories, Inc. ELW Class II 1996-12-30
K964659 ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM Dentsply Intl. EHD Class II 1996-12-23
K963699 BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY Belmont Equipment Corp. EHD Class II 1996-12-23
K964788 EL DORADO 55 Gateway Alloys, Inc. EJT Class II 1996-12-20
K964837 PACIFIC 56 (CB-40) Gateway Alloys, Inc. EJT Class II 1996-12-20
K964792 LA PLATA 40 Gateway Alloys, Inc. EJT Class II 1996-12-20
K964838 PALLADIA 85 (PM-13) Gateway Alloys, Inc. EJT Class II 1996-12-20
K964789 LA PLATA 39 Gateway Alloys, Inc. EJT Class II 1996-12-20
K964059 MICADENT Hampton Research KOJ Class II 1996-12-19
K964706 SOLDER 650 Gateway Alloys, Inc. EJS Class II 1996-12-16
K964708 SOLDER 615 Gateway Alloys, Inc. EJT Class II 1996-12-16
K964707 SOLDER 585 Gateway Alloys, Inc. EJS Class II 1996-12-16
K964705 SOLDER GPY Gateway Alloys, Inc. EJS Class II 1996-12-16
K964323 CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL Fen Dental Mfg., Inc. ELW Class II 1996-12-16
K964713 SOLDER GPW Gateway Alloys, Inc. EJS Class II 1996-12-16
K963747 REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. Whitehill Manufacturing, Inc. JET Class I 1996-12-16
K964158 JEL-40 (CODE NAME RD-0430) Jelenko Co. EJT Class II 1996-12-13
K964328 SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE Synthes (Usa) JEY Class II 1996-12-13
K963746 IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID Whitehill Oral Technologies, Inc. JES Class I 1996-12-12
K963979 ULTRADENT UNIVERSAL DENTIN SEALANT Ultradent Products, Inc. LBH Class II 1996-12-12
K964775 ARDENT FUTURA NON GAMMA-2 Ardent Production Development EJJ Class II 1996-12-10
K964040 TRUBYTE SOFT RELINE SYSTEM Dentsply Intl. EBI Class II 1996-12-06
K950259 COUPLING DEVICE FOR DENTAL PROSTHESIS Dr. Joseph E. Grasso, D.D.S. EGG Class I 1996-12-06
K964566 OZARK 20 Gateway Alloys, Inc. EJT Class II 1996-12-06
K964569 EL DORADO 58 Gateway Alloys, Inc. EJT Class II 1996-12-06
K964573 PIEDMONT 70 (CH-35) Gateway Alloys, Inc. EJT Class II 1996-12-06
K964567 EL DORADO 75 Gateway Alloys, Inc. EJT Class II 1996-12-06
K963922 ALPHA-DENT ROOT CANAL SEALER & FILLER Wallace A. Erickson & Co. KIF Class II 1996-12-06
K964568 OZARK 46 Gateway Alloys, Inc. EJT Class II 1996-12-06
K964572 PALLADIA 76 Gateway Alloys, Inc. EJT Class II 1996-12-06
K964476 DE ORO 77 Gateway Alloys, Inc. EJT Class II 1996-12-04
K963736 SOFT DENTURE REBASING RESIN Sybron Dental Specialties, Inc. EBI Class II 1996-12-04
K964578 FIBREKOR Jeneric/Pentron, Inc. EBF Class II 1996-12-03
K964477 OZARK 40 Gateway Alloys, Inc. EJT Class II 1996-12-02
K963862 TOUCH N' HEAT Sybron Dental Specialties, Inc. EAT Class II 1996-12-02
K963735 COJET SYSTEM Espe GmbH & Co. Kg. EBF Class II 1996-11-27
K963805 PRODIGY AC Sybron Dental Specialties, Inc. EBF Class II 1996-11-27
K964464 PACIFIC 52 (CB-39) Gateway Alloys, Inc. EJT Class II 1996-11-26
K964465 LA PLATA 34 (PM-25) Gateway Alloys, Inc. EJT Class II 1996-11-26
K962631 DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM Fair Image, Inc. EHD Class II 1996-11-26
K964478 OSAGE 76 Gateway Alloys, Inc. EJT Class II 1996-11-26
K963778 CDR-CAM Schick Technologies, Inc. EIA Class I 1996-11-22
K964466 PALLADIA 75 (PM-11) Gateway Alloys, Inc. EJT Class II 1996-11-20
K960770 MATCHMAKER/PROPAQUE PORCELAIN Davis Schottlander & Davis, Ltd. ELL Class II 1996-11-19
K963786 TEMPFIL F Sybron Dental Specialties, Inc. EBG Class II 1996-11-19
K963891 RX 96E Jeneric/Pentron, Inc. EJH Class II 1996-11-19
K963927 TEAM CARIES INDICATOR Centrix, Inc. LFC Class II 1996-11-15
K961665 O BUTMENT ET IMPLANT O Co., Inc. DZE Class II 1996-11-15
K963737 HYCEM APLICAP Espe GmbH & Co. Kg. EMA Class II 1996-11-15
K963224 STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT Steri-Oss, Inc. DZE Class II 1996-11-14
K960868 B.A.S.I.C. DENTAL IMPLANT SYSTEM Danlin Products, Inc. DZE Class II 1996-11-14
K963609 PHASE PLUS Zhermack S.P.A. ELW Class II 1996-11-14
K963394 OSTEOMED TRAM Osteomed Corp. JEY Class II 1996-11-14
K963921 PULPDENT SEAL-RITE UDMA Pulpdent Corp. EBC Class II 1996-11-12
K963912 TYCO BABY SESAME STREET SOFT TEETHER Regu-Tech Assoc., Inc. KKO Class II 1996-11-06
K963897 STERI-OSS SINUS AUGMENTATION KIT Steri-Oss, Inc. EMM Class I 1996-11-06
K964140 GLUMA CONDITIONER Heraeus Kulzer, Inc. KLE Class II 1996-11-05
K960267 TBM SPONGE Biocoll Laboratories, Inc. LYC Class II 1996-11-05
K963401 TPS APICAL IMPLANT Steri-Oss, Inc. DZE Class II 1996-11-05
K964000 BISFIL 2B Bisco, Inc. KLE Class II 1996-11-05
K963121 FIXTURE MOUNT KIT Steri-Oss, Inc. DZE Class II 1996-11-05
K963766 3M PROPLUS SYSTEM 3M Company ELW Class II 1996-10-31
K963205 ALGINMAX, ORTHOCHROME American Tooth Industries ELW Class II 1996-10-29
K963144 GC BASELINE GC America, Inc. EBI Class II 1996-10-29
K963740 LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS Howmedica Leibinger, Inc. JEY Class II 1996-10-28
K961418 OSTEOMED MSS Osteomed Corp. DZL Class II 1996-10-25
K963110 JETLITE J. Morita USA, Inc. EBZ Class II 1996-10-24
K963664 DENTAL HANDPIECE AND ACCESSORY Filmtech, Inc. EFB Class I 1996-10-24
K963209 PROSTYLE COMPACT Planmeca Oy KLC Class I 1996-10-24
K962610 DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES Implant Integration Systems, Inc. DZE Class II 1996-10-18
K962845 REPLACE HA COATED IMPLANTS Steri-Oss, Inc. DZE Class II 1996-10-18
K962014 3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC. Implant Innovations, Inc. DZE Class II 1996-10-18
K962877 MIDWEST 300 SE Midwest Dental Products Corp. EFB Class I 1996-10-18
K962844 REPLACE TPS COATED IMPLANTS Steri-Oss, Inc. DZE Class II 1996-10-18
K940643 OSMED EPI-GUIDE Thm Biomedical, Inc. LYC Class II 1996-10-15
K963050 TRADITION P, PUSH BUTTON HANDPIECE Midwest Dental Products Corp. EFB Class I 1996-10-11
K962394 IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS Implant Integration Systems, Inc. DZE Class II 1996-10-11
K963652 PULPDENT DESENSITIZER Pulpdent Corp. EBF Class II 1996-10-11
K962733 CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920) Union Broach, Div. Moyco Industries, Inc. EMA Class II 1996-10-11
K962941 OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE Deep Trading Corp. LCN Class I 1996-10-08
K962909 DENTAL PREP WASH AND PREP DISINFECT William J. Day EBF Class II 1996-10-07
K962647 ANGLED ABUTMENT Straumann USA DZE Class II 1996-10-07
K963311 TEAM ETCH Centrix, Inc. EBF Class II 1996-10-07
K962812 GLUMA DESENSITIZER/GLUMA 3 PRIMER Heraeus Kulzer, Inc. KLE Class II 1996-10-07
K962624 RESOLUT REGENERATIVE MATERIAL W. L. Gore & Associates, Inc. LYC Class II 1996-10-03

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