meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
36
Latest Decision
1997-12-05

Clearances · page 75 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K973433 STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT Steri-Oss, Inc. DZE Class II 1997-12-05
K973423 STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT Steri-Oss, Inc. DZE Class II 1997-12-05
K973771 DENTAL/SURGICAL DRILLS, BURS, TAPS Implant Innovations, Inc. DZE Class II 1997-12-04
K973782 AQUASIL XLV SMART WETTING IMPRESSION MATERIAL Dentsply Intl. ELW Class II 1997-12-04
K973976 EPIC-FLO Parkell, Inc. EBF Class II 1997-12-04
K973370 AQUAPLAST PALATAL STENT Wfr/Aquaplast Corp. EMA Class II 1997-12-02
K973353 BONDING BASE Straumann USA DZE Class II 1997-12-02
K973484 CHIN DISTRACTOR Howmedica, Inc. JEY Class II 1997-12-02
K973495 GLENROE GLOW IN DARK ELASTOMERIC LIGATURES Glenroe ECI Class I 1997-12-01
K973402 STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM Steri-Oss, Inc. DZE Class II 1997-11-26
K972945 AURENORM 68 Aurex Precious Metal Industries (Pty)Ltd EJS Class II 1997-11-26
K973372 AUROFILM 2000 Metalor Dental USA Corp. EJT Class II 1997-11-26
K973541 MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED Medental Intl. EBC Class II 1997-11-25
K972351 SENDAX MDI (MINI DENTAL IMPLANT) Sendax Mdic Management, Inc. DZE Class II 1997-11-24
K973881 PROSPECTOR PLUS (CODE NAME : RD-0508) J.F. Jelenko & Co., Inc. EJT Class II 1997-11-24
K973694 PROVIL NOVO Heraeus Kulzer, Inc. ELW Class II 1997-11-24
K973397 SYNTAC SPRINT Ivoclar North America, Inc. EMA Class II 1997-11-21
K973776 REFLECTIONS Cdb Corp. DYW Class II 1997-11-21
K973642 ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 Instrumentarium Imaging, Inc. EHD Class II 1997-11-21
K973521 VARIABLE PARALLEL PIN Sulzer Calcitek, Inc. DZE Class II 1997-11-20
K973275 KLS-MARTIN INTRAORAL DISTRACTOR KLS-Martin L.P. MQN Class II 1997-11-20
K973248 IMTEC BONE COLLECTOR SYSTEM Imtec Corp. EHZ Class I 1997-11-19
K973145 TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM Sofamor Danek USA,Inc. JEY Class II 1997-11-19
K973288 STABILOR HN Degussa Corp. EJS Class II 1997-11-19
K973180 IMTEC BONE TAC Imtec Corp. DZL Class II 1997-11-18
K973262 KETAC-FIL APLICAP PLUS Espe GmbH & Co. Kg. EMA Class II 1997-11-17
K973257 VERSAETCH Centrix, Inc. EBF Class II 1997-11-17
K954030 BONE-LOCK Leibinger GmbH DZE Class II 1997-11-14
K973185 AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE American Dental Products, Inc. KLE Class II 1997-11-14
K972553 LANG DENTAL RESIN A97 FIBRED PINK Lang Dental Mfg. Co., Inc. EBI Class II 1997-11-13
K973049 IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM Imcor DZE Class II 1997-11-13
K972769 OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4 Opti-Max DZE Class II 1997-11-13
K973038 ADJUSTABLE THERASNORE Distar, Inc. LRK Class II 1997-11-12
K973056 BONE GRAFT SCREW SYSTEM Bicon, Inc. DZL Class II 1997-11-12
K973018 SYNTHES MINI LENGTHENING APPARATUS Synthes (Usa) MQN Class II 1997-11-10
K973476 KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER Eastman Kodak Company EHD Class II 1997-11-10
K972965 STERI-OSS UNTIL IMPLANT CEMENT Steri-Oss, Inc. EMA Class II 1997-11-07
K973667 VITAPEX PRE-LOADED DENTAL SYRINGE Neodental Chemical Products Co., Ltd. KIF Class II 1997-11-06
K973200 CARIES STAIN Parkell, Inc. LFC Class II 1997-11-06
K972842 INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE Interpore Intl. LYC Class II 1997-10-30
K973539 ROEKO CALCIUM HYDROXIDE POINTS Roeko USA, Inc. EJK Class II 1997-10-30
K972924 SURGIC II IMPLANT CONTROL UNIT Nsk Nakanishi, Inc. EBW Class I 1997-10-30
K972648 SONICSYS INLAY Ivoclar North America, Inc. EIH Class II 1997-10-30
K972292 SOLIDEX Shofu Dental Corp. EBF Class II 1997-10-29
K973492 DENTALVIEW PERIOVIEW SYSTEM Dentalview, Inc. EIA Class I 1997-10-21
K973343 HYDROFLEX GC America, Inc. ELW Class II 1997-10-21
K970499 BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM Nobel Biocare Uas, Inc. DZE Class II 1997-10-16
K973247 VINTAGE HALO Shofu Dental Corp. EIH Class II 1997-10-16
K973265 VERABOND 2V Aalba Dent, Inc. EJH Class II 1997-10-16
K972910 PORS ON LITE Degussa Corp. EJT Class II 1997-10-14
K973175 TONGUE KLEAN Softek Ent. LCN Class I 1997-10-14
K972607 PLATALLOY Aalba Dent, Inc. EJH Class II 1997-10-10
K962774 OSTEOMED QUICKFIX Osteomed Corp. DZL Class II 1997-10-10
K973062 TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE Medidenta Intl., Inc. EFA Class I 1997-10-09
K972569 E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION Nsk Nakanishi, Inc. EGS Class I 1997-10-08
K972968 ROTOGRAPH PLUS Chicago X-Ray Systems, Inc. EHD Class II 1997-10-08
K973086 PLA-96P Southern Dental Industries, Inc. EJJ Class II 1997-10-07
K973245 TOKUSO REBASE MR. BOND Tokuyama America, Inc. KLE Class II 1997-10-07
K973088 PLS-96P Southern Dental Industries, Inc. EJJ Class II 1997-10-03
K972844 TEMP BOND CLEAR Kerr Dental Materials Center EMA Class II 1997-10-03
K972871 GENESIS Pacific Rim Dental, Inc. ELW Class II 1997-10-02
K972892 CAVIT-LC Espe GmbH & Co. Kg. EBF Class II 1997-10-02
K971733 2 BOND 2 Heraeus Kulzer, Inc. KLE Class II 1997-10-02
K972445 PULPDENT OX-OUT Pulpdent Corp. EMA Class II 1997-10-02
K971794 ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE Frantz Design, Inc. LRK Class II 1997-09-29
K972101 SOLITAIRE Heraeus Kulzer, Inc. KLE Class II 1997-09-29
K972858 KERR NEXUS ONE BOTTLE ADHESIVE Sybron Dental Specialties, Inc. KLE Class II 1997-09-26
K972463 THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Biomedics JEY Class II 1997-09-25
K972985 SPLINT IT Jeneric/Pentron, Inc. ELS Class II 1997-09-24
K973035 VIOLA II DENTAL CAMERA SYSTEM Innovative Medical Systems, Inc. EIA Class I 1997-09-24
K972436 T1 LINE DENTAL HANDPIECES Siemens AG EFB Class I 1997-09-22
K972949 AURELUX BIO Y85PF Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-09-18
K972424 SILENTNITE Glidewell Laboratories LRK Class II 1997-09-18
K972417 THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM Bicon, Inc. DZE Class II 1997-09-17
K972827 IPS EMPRESS COSMO INGOT Ivoclar North America, Inc. EIH Class II 1997-09-17
K970589 MICROETCHER AP Danville Engineering, Inc. KOJ Class II 1997-09-17
K972875 COSMOPOST Ivoclar North America, Inc. ELR Class I 1997-09-17
K972313 THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. DZE Class II 1997-09-16
K972890 ENLIGHT (TENTATIVE NAME) Sybron Dental Specialties, Inc. DYH Class II 1997-09-16
K972943 AURECAST 92 Aurex Precious Metal Industries (Pty)Ltd EJT Class II 1997-09-16
K972573 LIQCRYLIC PRO DENTAL RESIN Dentsply Intl. EBI Class II 1997-09-16
K972312 SIEMENS ORTHOPHOS DS/DS CEPH Siemens AG EHD Class II 1997-09-15
K973388 DENTIN CONDITIONING AND ADHESIVE (BOND 1) Jeneric/Pentron, Inc. KLE Class II 1997-09-12
K972475 AURADAPT AUBTMENT SYSTEM Nobel Biocare Uas, Inc. NHA Class II 1997-09-12
K971594 FLOW-RITE Pulpdent Corp. EBF Class II 1997-09-12
K971762 BELLEGLASS HP ENAMEL REPAIR MATERIAL Sybron Dental Specialties, Inc. EBF Class II 1997-09-12
K972249 ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD Pelton & Crane Co. EHD Class II 1997-09-12
K971727 DCI WATER PURIFIER Dental Components, Inc. EIA Class I 1997-09-12
K972285 GETTIG STYRL-JECT DELIVERY SYSTEM Gettig Pharmaceutical Instrument Co. EJI Class II 1997-09-11
K962422 INFIMED DENTAL SYSTEM Infimed, Inc. EHD Class II 1997-09-11
K964755 MICROJET CAVITY PREPARATION SYSTEM Midwest Dental Products Corp. KOJ Class II 1997-09-11
K972644 BREATH-SO-FRESH TONGUE CLEANER Intl. Dental Design Specialists, Inc. LCN Class I 1997-09-11
K971869 FINESSE ALL-CERAMIC SYSTEM Dentsply Intl. EIH Class II 1997-09-11
K972376 IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE Glenwood, LLC EFB Class I 1997-09-10
K972375 IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE Glenwood, LLC EFB Class I 1997-09-10
K950261 DEVICE FOR PROVIDING QUICK COUPLING FOR DENTAL PROSTHESES Dr. Joseph E. Grasso, D.D.S. DZE Class II 1997-09-09
K961381 KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS The Emerging Technologies Group DZE Class II 1997-09-09
K950260 QUICK COUPLING DEVICE FOR DENTAL PROSTHESES Dr. Joseph E. Grasso, D.D.S. DZE Class II 1997-09-09
K972485 CIMPAT N Arent, Fox, Kintner, Plotkin & Kahn EMA Class II 1997-09-08
K972168 SIDEXIS DIGITAL RADIOGRAPHY SYSTEM Pelton & Crane Co. EHD Class II 1997-09-05

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