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Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
52
Latest Decision
1986-03-12

Clearances · page 113 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K854645 GOLD AIR, GOLD LIGHT Alpine Dental Equipment Co. EFB Class I 1986-03-12
K860058 DENPAX Nissho Iwai American Corp. EBR Class I 1986-03-12
K854467 S.T.P.B SOFT TISSUES PROTECTIVES BLADES Nortex USA, Inc. EEJ Class I 1986-03-12
K854529 INLAY WAX REGULAR The Hygenic Corp. EGD Class I 1986-03-10
K854641 SOLAR F Alpine Dental Equipment Co. EIA Class I 1986-03-10
K854646 VEGA DENTAL OPERATING LIGHT Alpine Dental Equipment Co. EBA Class I 1986-03-06
K854741 X-RANGE 65 Alpine Dental Equipment Co. EHD Class II 1986-03-06
K854738 SPARTAN SOLDER Williams Gold Refining Co., Inc. EJH Class II 1986-03-06
K854697 TUBING HANDPIECE REPLACEMENT Almore Intl., Inc. EFB Class I 1986-03-06
K855136 FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE Union Broach, Div. Moyco Industries, Inc. EKS Class I 1986-03-06
K854702 PLASTIC MOUNTING RINGS Almore Intl., Inc. EJP Class I 1986-03-06
K855037 TRU-COLOR Veritas Dental Co., Inc. EIH Class II 1986-03-06
K854749 STARTANIUS DENTAL IMPLANT SYSTEM Park Dental Research Corp. DZE Class II 1986-03-06
K855111 DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES Pacific Union Dental, Inc. ELW Class II 1986-03-06
K854701 RETRACT-A-CORD Almore Intl., Inc. JES Class I 1986-03-06
K855112 DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS Pacific Union Dental, Inc. ELW Class II 1986-03-06
K855113 FLOSS HOLDER (PLASTIC) Pacific Union Dental, Inc. JES Class I 1986-03-06
K854527 STICKY WAX The Hygenic Corp. EGD Class I 1986-03-04
K854530 PREMIUM FLEXI-TOUGH The Hygenic Corp. EGD Class I 1986-03-04
K855167 DYNA SYSTEM Parker Laboratories, Inc. EGG Class I 1986-03-04
K854795 HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER Fran Hazelton Co. EIS Class I 1986-03-04
K854803 CHAMELEON BONDING KIT Pentron Corp. EBF Class II 1986-03-04
K854430 RIGIDENT CREAM Armkel, LLC KOT Class I 1986-03-04
K855032 IMZ INTRAMOBILE CYLINDER IMPLANT Interpore Intl. DZE Class II 1986-03-03
K854887 MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT Walter Lorenz Surgical, Inc. EMH Class I 1986-02-28
K854711 FIBRELIGHT ILLUMINATING ORAL RETRACTORS Downs Surgical , Ltd. EIG Class I 1986-02-25
K854763 CERAPEARL Kyocera International, Inc. EIH Class II 1986-02-21
K854977 FIBER MESH Pulpdent Corp. of America DZE Class II 1986-02-20
K844844 ESPE NIMETIC-GRIP Espe GmbH (Us) DYH Class II 1986-02-13
K853841 HARMO SONIC U.S. Shizai Corp. ELC Class II 1986-02-04
K854588 INSTA-GLAZE George Taub Products & Fusion Co., Inc. EJR Class I 1986-02-04
K855224 ACROMED NESTED BONE PLATE Buckman Co., Inc. JEY Class II 1986-02-04
K854882 PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT Lee Pharmaceuticals EBC Class II 1986-01-30
K855030 CHAMPY BONE PLATES & BONE SCREWS Advanced Biosearch Assn. JEY Class II 1986-01-30
K854957 AUSTENAL DENTAL COMPOSITE RESIN Austenal Dental, Inc. EBD Class II 1986-01-30
K854878 H40 BASE METAL ALLOY Jeneric Ind. EJH Class II 1986-01-30
K854855 PROOF ALGINATE IMPRESSION MATERIAL Sybron Corp. ELW Class II 1986-01-30
K854633 JACKSON RARE EARTH MAGNETIC ATTACHMENT Solid State Innovations, Inc. EGG Class I 1986-01-30
K855005 FIBER MESH Fiber Mesh, Inc. DZE Class II 1986-01-30
K852525 SATALEC PIEZOTEC Spelna, Inc. ELC Class II 1986-01-30
K854644 MANTA DENTAL CHAIR Alpine Dental Equipment Co. KLC Class I 1986-01-23
K854886 WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS Walter Lorenz Surgical, Inc. JEY Class II 1986-01-21
K853090 CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO Psp Dental Co., Ltd. EMA Class II 1986-01-21
K853451 TROLL-BITE Trollplast, Inc. EGZ Class I 1986-01-21
K853091 CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE Psp Dental Co., Ltd. EMA Class II 1986-01-21
K854699 TUBING SYRING Almore Intl., Inc. ECB Class I 1986-01-06
K854285 GDC 1453 CASTING ALLOY Deringer-Ney, Inc. EJH Class II 1985-12-27
K852522 SATALEC SERVOTOME Spelna, Inc. EKZ Class II 1985-12-27
K854347 HYBRID POINTS Shofu Dental Corp. DZP Class I 1985-12-27
K854495 GRESCO N.P. DENTAL ALLOY Gresco Products, Inc. EJH Class II 1985-12-27
K854494 CERAM-ETCH Gresco Products, Inc. EBC Class II 1985-12-23
K852630 DEN-MAT PAINT-ON RUBBER DAM Den-Mat Corp. EIE Class I 1985-12-18
K854253 ROOT CANAL FILLING RESIN Dentsply Intl. KIF Class II 1985-12-16
K853767 FLOSPIK Medelco , Ltd. JES Class I 1985-12-02
K854050 EXCEL BRACKET ADHESIVE Johnson & Johnson Professionals, Inc. DYH Class II 1985-11-26
K854088 UNITEK LIFT-OFF DEBRACKETING INSTRUMENT Unitex Corp. JEX Class I 1985-11-26
K853055 LIGHT CURE FILLING MATERIAL Foremost Dental Mfg., Inc. EBF Class II 1985-11-19
K853707 DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES Dentsply Intl. EIH Class II 1985-11-19
K853845 ALLOY B North American Alloys, Inc. EJH Class II 1985-11-19
K853882 SUPER SLICK Tang Products KMT Class I 1985-11-18
K853698 SCOTCHPRIME CERAMIC PRIMER 3M Company EIH Class II 1985-11-14
K854042 RESIN TRAY IMPRESSION MATERIAL Dentsply Intl. EBH Class I 1985-11-07
K853523 VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE Dentsply Intl. DYH Class II 1985-11-07
K853982 GOLDEN CERAMIC Wiliams Gold Refining Co., Inc. EJT Class II 1985-11-07
K853431 DENTAL CEMENT Dentsply Intl. EBF Class II 1985-10-31
K853160 AUSTENAL MODIFIED ACRYLIC DENTURE RESIN Austenal Dental, Inc. ELM Class II 1985-10-31
K852975 INTERPORE 200 POROUS HYDROXYAPATITE Inrterpore Intl. DZC Class I 1985-10-31
K853788 DB PRECISION IMPLANT SYSTEM Driskell Bioengineering DZE Class II 1985-10-31
K844446 BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC. Pulpdent Corp. of America ELW Class II 1985-10-29
K852816 FREEDOM LINE LUBRICATED MODELS LS-2-5, LT-6-10 Apollo Dental Products, Inc. EIA Class I 1985-10-24
K852895 CERAMIC ALLOY NO. DW 179 Williams Gold Refining Co., Inc. EJH Class II 1985-10-21
K852766 HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI Orthomatrix, Inc. LYC Class II 1985-10-21
K853447 POLYCARB WATER SET Pulpdent Corp. of America EMA Class II 1985-10-16
K852305 FLEXIROOT Facial Alveodental Implant Rehabilitation, Inc. DZE Class II 1985-10-16
K851733 DENTAL PORCELAIN-VARIOUS Excelco Intl., Inc. ELL Class II 1985-10-16
K853183 ENDODONTIC ELECTRONIC SPREADER HEATER Sturgeon Engineering Co. EKK Class I 1985-10-16
K852199 OSTEOGRAF 2040 OSTEOGRAF 4060 Osteotech, Inc. LYC Class II 1985-10-07
K852868 WUNDERSHADE Harry J. Bosworth Co. EBF Class II 1985-09-27
K852691 ODONTO TOOTHBRUSH Action Hygiene Products, Inc. EFW Class I 1985-09-27
K853498 PERFECT 10 North American Alloys, Inc. EJH Class II 1985-09-27
K852742 OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40 Coors Biomedical Co. LYC Class II 1985-09-26
K851524 SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE Specialites Septodont DZM Class I 1985-09-23
K852741 DURA CONDITIONER Reliance Dental Mfg. Co. EBI Class II 1985-09-23
K852755 UNIVAR UNIVERSAL DENTIN VARNISH Scientific Pharmaceuticals, Inc. LBH Class II 1985-09-23
K852802 DENAR DENTAL IMPLANT Denar Corp. DZE Class II 1985-09-23
K852682 CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG Calcitek, Inc. LYC Class II 1985-09-23
K851515 HERAENIUM CA Heraeus Dental Gold Corp. EJH Class II 1985-09-23
K852765 HA-2000 HYDROXYLAPATITE Orthomatrix, Inc. LYC Class II 1985-09-23
K853093 PSP TEMP - TRAY Psp Dental Co., Ltd. EBH Class I 1985-09-06
K852170 EZX YELLOW, BLUE OR ORANGE Strong Marketing EGZ Class I 1985-09-05
K851095 INTRAORAL DENTAL X-RAY SYSTEM 70-X Trophy Radiologie EHD Class II 1985-09-03
K852894 ORMCO TRANSMANDIBULAR IMPLANT Ormco Corp. MDL Class II 1985-08-29
K852093 ALLOY 7 Williams Gold Refining Co., Inc. EJS Class II 1985-08-23
K853282 CENTRIX RIBBON TUBES Centrix, Inc. EID Class I 1985-08-23
K852179 CERAMIC ORTHODONIT APPLIANCE Gac Intl., Inc. EJF Class I 1985-08-20
K844845 ESPE KETAC-BOND Espe GmbH (Us) EBD Class II 1985-08-19
K853002 BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR) Bisco, Inc. EBF Class II 1985-08-16
K853052 INTEGRITY Dentsply Intl. EBG Class II 1985-08-16
K853001 BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE) Bisco, Inc. EBF Class II 1985-08-16
K852744 CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR The S. S. White Co. EBF Class II 1985-08-16

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