FDA 510(k) Applications for Medical Device:
Resin, Denture, Relining, Repairing, Rebasing

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K061501 ACI, INC. 5830 WOODSON
MISSION KS 66202
K230115 Aidite (Qinhuangdao) Technology Co., Ltd No. 9 Dushan Road, Economic and Technological
Qinhuangdao 066000
K082180 ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS 11234 EL CAMINO REAL,
SAN DIEGO CA 92130
K021121 AROMACRYL, LLC 1013 EAST THIRD ST.
ROYAL OAK MI 48067
K970522 AUSTENAL, INC. 4101 WEST 51ST ST.
CHICAGO IL 60632-4287
K001640 BIOSOFT INTERNATIONAL CORP. 944 WILLIAMS ST.
TRENTON NJ 08610
K141439 BISCO, INC. 1100 WEST IRVING PARK RD.
SCHAUMBURG IL 60193
K034024 BISCO, INC. 1100 WEST IRVING PARK RD.
SCHAUMBURG IL 60193
K033472 BISCO, INC. 1100 WEST IRVING PARK RD.
SCHAUMBURG IL 60193
K991687 BOSWORTH CO. 7227 NORTH HAMLIN AVE.
SKOKIE IL 60076-3999
K052780 BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT SCHWARZWALDSTR 11
TUTTLINGEN 78532
K974160 BRUXCARE, L.L.C. 6331 PINESHADE LN.
HOUSTON TX 77008
K170375 CMP Industries LLC 413 N. Pearl St.
Albany NY 12207
K072402 CMP INDUSTRIES LLC. 413 NORTH PEARL ST.
ALBANY NY 12207
K033020 CMP INDUSTRIES LLC. 413 NORTH PEARL ST.
ALBANY NY 12207
K072851 CMP INDUSTRIES LLC. 413 NORTH PEARL ST.
ALBANY NY 12207
K081537 COMFORT AND FLEXIBLE SYSTEMS 845 ARONSON LAKE COURT
ROSWELL GA 30075
K063626 COSMETIC DENTAL MATERIALS INC 812 WATER ST. N.E.
ALBANY OR 97321
K993717 DAVIS SCHOTTLANDER & DAVIS, LTD. 54 RIVERVIEW AVE.
TONAWANDA NY 14150-5260
K001463 DAVIS SCHOTTLANDER & DAVIS, LTD. 124 E. MISSOURI AVE.
KANSAS CITY MO 64106
K212541 DeltaMed GmbH Raiffeisenstrasse 8a
Friedberg 61169
K230341 DeltaMed GmbH Raiffeisenstrasse 8a
Friedberg 61169
K011762 DENPLUS, INC. 1221 LABADIE, SUITE 205
LONGUEUIL, QUEBEC J4N 1E2
K991996 DENPLUS, INC. 4235 BEACONSFIELD
MONTREAL, QUEBEC H4A 2H4
K230410 Dental Direkt GmbH Industriezentrum 106-108
Spenge 32139
K160498 Dental Solutions, LLC 7701 Golden Valley Road
Golden Valley MN 55427
K990448 DENTAMAX, INC. 4311 S.W. RESEARCH WAY
CORVALLIS OR 97333
K042931 DENTATUS USA, LTD. 192 LEXINGTON AVE.
NEW YORK NY 10016
K220042 Dentca, Inc. 357 Van Ness Way, Ste 250
Torrance CA 90501
K143033 DENTCA, INC. 3608 Griffith Avenue
Los Angeles CA 90011
K162044 DENTCA, Inc. 357 Van Ness Way #250
Torrance CA 90501
K130680 DENTSOLL, INC. 8708 CAPEHART COVE
AUSTIN TX 78733
K061580 DENTSPLY INTERNATIONAL SUSQUEHANNA COMMERCE CTR. WEST
YORK PA 17404
K072713 DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST.
YORK PA 17404
K972573 DENTSPLY INTL. 570 WEST COLLEGE AVE.
YORK PA 17405-0872
K992956 DENTSPLY INTL. 570 WEST COLLEGE AVE.
YORK PA 17405-0872
K032892 DENTSPLY INTL. 570 WEST COLLEGE AVENUE
YORK PA 17404
K011560 DENTSPLY INTL. 570 WEST COLLEGE AVE.
YORK PA 17405-0872
K964040 DENTSPLY INTL. 500 WEST COLLEGE AVE.
YORK PA 17405
K190043 Dentsply Sirona 221 West Philadelphia Street, Suite 60W
York PA 17401
K191427 Dentsply Sirona 221 West Philadelphia Street
York PA 17401
K182422 Dentsply Sirona 221 West Philadelphia Street, Suite 60
York PA 17404
K161330 Dentsply Sirona 221 West Philadelphia Street
York PA 17404
K200461 Detax GmbH & Co. KG Carl-Zeiss-Strasse 4
Ettlingen 76275
K162654 DETAX GmbH & Co.KG Carl-Zeiss-Str. 4
Ettlingen 76275
K193623 DIO Corporation 66, Centum Seo-ro, Haeundae-gu
Busan 48058
K210828 DIO Corporation 66, Centumseo-ro, Haeundae-gu,
Busan 48058
K190790 DK Mungyo Corporation 248, Anha-ro, Hallim-myeon
Gimhae-si 50852
K200580 Dreve Dentamid GmbH Max-Planck-Strasse 31
Unna 59423
K191591 Enlighten Materials Co., Ltd 8F., NO.138, Sec.2, Jinshan S. Rd., Da-an Dist
Taipei 10642
K203641 EnvisionTEC GmbH Brusseler Stra▀e 51
Gladbeck D-45968
K991220 ESPE DENTAL AG ESPE PLATZ
SEEFELD, BAVARIA D-82229
K990763 ESPE DENTAL AG ESPE PLATZ
SEEFELD, BAVARIA D-82229
K991774 GC AMERICA, INC. 3737 WEST 127TH ST.
ALSIP IL 60803
K070698 GC AMERICA, INC. 3737 WEST 127TH ST.
ALSIP IL 60803
K070697 GC AMERICA, INC. 3737 WEST 127TH ST.
ALSIP IL 60803
K963144 GC AMERICA, INC. 3737 WEST 127TH ST.
ALSIP IL 60803
K982695 GC AMERICA, INC. 3737 WEST 127TH ST.
ALSIP IL 60803
K153253 GC AMERICA, INC. 3737 W. 127TH ST.
ALSIP IL 60803
K990736 GC AMERICA, INC. 3737 WEST 127TH ST.
ALSIP IL 60803
K984365 GC AMERICA, INC. 3737 WEST 127TH ST.
ALSIP IL 60803
K051358 GC AMERICA, INC. 3737 WEST 127TH ST.
ALSIP IL 60803
K061735 GLOBAL DENTAL PRODUCTS, INC. 1028 MCLEAN AVE
WANTAGH NY 11793
K153590 Global Dental Science 15730 N 83rd Way, Suite 101
Scottsdale AZ 85260
K222414 Graphy Inc. 603, #617, Ace Gasan Forhu, 225, Gasan digital 1-ro,
Seoul 08503
K083479 GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE.DR.
TONAWANDA NY 14150
K040881 GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE.
TONAWANDA NY 14151-5111
K033632 GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE.DR.
TONAWANDA NY 14150
K961200 HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE.
SKOKIE IL 60076
K981861 HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE.
SKOKIE IL 60076
K990699 HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE.
SKOKIE IL 60076
K981862 HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE.
SKOKIE IL 60076
K981691 HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE.
SKOKIE IL 60076
K231389 Harvest Dental Products, LLC 905 Columbia Street
Brea CA 92821
K222489 Harvest Dental Products, LLC 905 Columbia Street
Brea CA 92821
K043504 HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND IN 46614-2517
K961995 HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD.
IRVINE CA 92718-2595
K033629 HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND IN 46614-2517
K010800 HERAEUS KULZER, INC. 99 BUSINESS PARK DR.
ARMONK NY 10504
K043295 HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND IN 46614-2517
K111832 HERAEUS KULZER, LLC 300 HERAEUS WAY
SOUTH BEND IN 46614
K110037 HERAEUS KULZER, LLC 300 HERAEUS WAY
SOUTH BEND IN 46614
K021586 IMTEC CORP. 2401 NORTH COMMERCE
ARDMORE OK 73401
K021437 IMTEC CORP. 2401 NORTH COMMERCE
ARDMORE OK 73401
K103391 IVOCLAR VIVADENT, INC. 175 PINEVIEW DR.
AMHERST NY 14228
K060844 J. MORITA USA, INC. 9 MASON
IRVINE CA 92618
K002048 J.B.C AND CO. 6280 SOUTH VALLEY VIEW BLVD.,
LAS VEGAS NV 89118
K974727 J.B.C AND CO. 23691 VIA DEL RIO
YORBA LINDA CA 92887
K990056 J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR.
ARMONK NY 10504
K111177 JUELL DENTAL 2401 N COMMERCE
ARDMORE OK 73401
K111178 JUELL DENTAL 2401 N COMMERCE
ARDMORE OK 73401
K160918 JUVORA TECHNOLOGY CENTRE, HILLHOUSE INTERNATIONAL
THORNTON-CLEVELEYS FY5 4QD
K132725 JUVORA TECHNOLOGY CENTRE
THORNTON-CLEVELEYS, LANCASHIRE FY5 4QD
K181331 Juvora, Ltd. Technology Centre, Hillhouse International
Thornton-Clevelys FY5 4QD
K992609 KAY SEE DENTAL MFG. CO. 124 EAST MISSOURI AVE.
KANSAS CITY MO 64106-1294
K980616 KOHLER MEDIZINTECHNIK GMBH & CO. KG DANNINGEN 9
NEUHAUSEN D-78579
K152270 KOREA ENGINEERING PLASTICS CO., LTD. 216,217,218, B BLDG, 17, GOSAN-RO 148 BEON-GIL
GUNPO-SI 435-833
K163482 Lang Dental Manufacturing Co., Inc. 175 Messner Drive PO Box 969
Wheeling IL 60090
K152981 LANG DENTAL MANUFACTURING COMPANY, INC 175 MESSNER DRIVE
WHEELING IL 60090
K072580 LANG DENTAL MFG. CO., INC. 175 MESSNER DR.
WHEELING IL 60090-0969
K100653 LANG DENTAL MFG. CO., INC. 175 MESSNER DR.
WHEELING IL 60090-0969
K081981 LANG DENTAL MFG. CO., INC. 175 MESSNER DR.
WHEELING IL 60090-0969
K972553 LANG DENTAL MFG. CO., INC. 175 MESSNER DR.
WHEELING IL 60090
K112397 LANG DENTAL MFG. CO., INC. P.O BOX 969
WHEELING IL 60090-0969
K081514 LANG DENTAL MFG. CO., INC. 175 MESSNER DR.
WHEELING IL 60090-0969
K081884 MAJOR PRODOTTI DENTARI S.P.A. VIA LUIGI EINAUDI 23
MONACALIERI (TORINO) I-10024
K082153 MAJOR PRODOTTI DENTARI S.P.A. VIA LUIGI EINAUDI 23
MONACALIERI (TORINO) I-10024
K991577 MANUFACTURERA DENTAL CONTINENTAL 30001 GOLDEN HARTERN #334
HAGUNA NYVEL CA 92677
K140758 MERZ DENTAL GMBH 5616 MARIOLA PL NE
ALBUQUERQUE NM 87111
K130076 MERZ DENTAL GMBH 5616 MARIOLA PL NE
ALBUQUERQUE NM 87111
K063170 MICERIUM S.P.A. VIA MARCONI 83
AVENGO 16030
K984467 MICRO DENTAL LABORATORIES 6665 AMADOR PLAZA RD., #200
DUBLIN CA 94568
K032773 MYCONE DENTAL SUPPLY CO., INC. 616 HOLLYWOOD AVE.
CHERRY HILL NJ 08002
K983876 MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND 616 HOLLYWOOD AVE.
CHERRY HILL NJ 08002
K152051 Mycone Dental Supply Co., t/a Keystone Industries t/a Keystone Industries, Mizzy & Deepak Products
Myerstown PA 17067
K172764 Mycone Dental Supply Company, Inc. (aka Keystone Industries) 480 S Democrat Road
Gibbstown NJ 08027
K230098 Myerson, LLC 5106 North Ravenswood Avenue
Chicago IL 60640-2713
K011820 NATS CORP. 30 NORTHPORT RD.
SOUND BEACH NY 11789-1734
K102874 NEW STETIC 962 ALLEGRO LANE
APOLLO BEACH FL 33572
K031070 NOBEL BIOCARE AB 22725 SAVI RANCH PKWY.
YORBA LINDA CA 92887
K113608 NUXEN S.R.L. 9741 JUAN B JUSTO
BUENOS AIRES C1408ALB
K113788 NUXEN S.R.L. J B JUSTO 9741, PB
BUENOS AIRES C1408ALB
K210189 Pac-Dent, Inc. 670 Endeavor Circle
Brea CA 92821
K181220 Park Dental Research Corporation 2401 N. Commerce Street Suite E
Ardmore OK 73401
K974865 PARKELL, INC. 155 SCHMITT BLVD.
FARMINGDALE NY 11735
K053516 PARKELL, INC. 155 SCHMITT BLVD.
FARMINGDALE NY 11735
K150454 PERFLEX 7 GIBOREY ISRAEL ST., INDUSTRIAL AREA POLEG
NETANYA 4250407
K153546 POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY VOLCJA DRAGA 42
VOLCJA DRAGA 5293
K962374 POLYDENTIA USA 1819 SO. MAY ST.
CHICAGO IL 60608
K973542 PRESSING DI MONTICELLI RAG. STEFANO 4311 SW RESEARCH WAY
CORVALLIS OR 97333
K213765 Prismatik Dentalcraft, Inc. 2144 Michelson Drive
Irvine CA 92612
K210298 Pro3dure Medical GmbH Am Burgberg 13
Iserlohn 58642
K151646 PROTECH PROFESSIONAL PRODUCTS, INC. 2900 N.W. COMMERCE PARK DRIVE, STE 10
BOYNTON BEACH FL 33426
K983547 PROTECH, INC. 6421 CONGRESS AVENUE, #102
BOCA RATON FL 33487
K072479 RAPID INJECTION SYSTEMS CORP. 30 NORTHPORT RD.
SOUND BEACH NY 11789
K122348 RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) 3 RUE LOUIS NEEL
ST. EGREVE 38120
K013881 RIBBOND, INC. 1402 3RD AVE., SUITE 1030
SEATTLE WA 98101-2118
K983357 ROYDENT DENTAL PRODUCTS, INC. 1010 WEST HAMLIN RD.
ROCHESTER HILLS MI 48309
K984483 S & C POLYMER GMBH ROBERT-BOSCH-STR. 5
ELMSHORN
K011277 S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5
ELMSHORN D-25335
K053328 SATELEC 130 GAITHER DRIVE
MT. LAUREL NJ 08054
K052073 SCHUTZ-DENTAL GMBH DIESELSTRASSE 5-6
ROSBACH, HESSEN D-61191
K220680 Shandong Huge Dental Material Corporation No. 68 Shanhai Road, Donggang District
Rizhao City 276800
K213994 Shandong Huge Dental Material Corporation No. 68 Shanhai Road, Donggang District
Rizhao City 276800
K073040 SMH BIOMATERIAL AG 3537 TEASLEY LANE
DENTON TX 76210
K220979 SprintRay Inc 2705 Media Center Drive, Suite 100A
Los Angeles CA 90065
K230445 SprintRay Inc. 2705 Media Center Drive, Suite 100A
Los Angeles CA 90065
K221678 SprintRay Inc. 2705 Media Center Drive, Suite 100A
Los Angeles CA 90065
K992176 ST. GEORGE TECHNOLOGY, INC. P.O. BOX 1586
YORK PA 17405
K984341 STERNGOLD/IMPLAMED 23 FRANK MOSSBERG DR.
ATTLEBORO MA 02703-0967
K011788 STICK TECH LTD. 80 PARKWAY WEST
MOUNT VERNON NY 10552
K021126 STICK TECH LTD. 80 PARKWAY WEST
MOUNT VERNON NY 10552
K030072 STICK TECH LTD. 80 PARKWAY WEST
MOUNT VERNON NY 10552
K011799 STICK TECH LTD. 80 PARKWAY WEST
MOUNT VERNON NY 10552
K003333 STICK TECH LTD. 80 PARKWAY WEST
MOUNT VERNON NY 10552
K003334 STICK TECH LTD. 80 PARKWAY WEST
MOUNT VERNON NY 10552
K220771 Stratasys Ltd 1 Holtzman St. Science Park
Rehovot 7612401
K971138 SULTAN CHEMISTS, INC. 85 WEST FOREST AVE.
ENGLEWOOD NJ 07631
K150511 SUN MEDICAL CO., LTD 571-2 FURUTAKA-CHO
MORIYAMA CITY 524-0044
K143265 SUN MEDICAL CO., LTD. 571-2 FURUTAKA-CHO
MORIYAMA CITY 524-0044
K981448 SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE.
ORANGE CA 92667
K963736 SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE.
ORANGE CA 92867
K102207 SYNCA MARKETING, INC. 12946 KIMBERLEY LN
HOUSTON TX 77079
K071245 TALON ACRYLICS, INC. 850 N.E. 102ND AVE.
PORTLAND OR 97220-4007
K172407 The Myerson Company Limited 3 Trinity Avenue
Laventille
K012882 THERMOELASTIC TECHNOLOGIES, INC. 962 ALLEGRO LN.
APOLLO BEACH FL 33572
K123396 THERMOPLASTIC COMFORT SYSTEMS, INC. 2619 LIME AVENUE
SIGNAL HILL CA 90755
K142894 Thermoplastic Comfort Systems, Inc. 2619 Lime Avenue
Signal Hill CA 90755
K053060 THERMOPLASTIC COMFORT SYSTEMS, INC. 2075 E. 27TH ST.
SIGNAL HILL CA 90755
K022641 TOKUYAMA AMERICA, INC. 2000 M ST. NW
WASHINGTON DC 20036
K982537 TOKUYAMA AMERICA, INC. 2000 M ST. NW
WASHINGTON DC 20036
K953589 TOKUYAMA AMERICA, INC. C/O GRAHAM & JAMES
WASHINGTON DC 20036
K112445 TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100
WASHINGTON DC 20005
K170549 Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku
Tokyo 110-0016
K190940 Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku
Tokyo 110-0016
K030663 TOKUYAMA DENTAL CORPORATION 2000 M ST. N.W. 7TH FLOOR
WASHINGTON DC 20036-3307
K081554 TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100
WASHINGTON DC 20005
K983461 TRANS-ATLANTIC DENTAL 46 ARCTIC PKWY.
TRENTON NJ 08638-3041
K111709 UNIX-JAPAN CO., LTD. 10920 WILSHIRE BLVD
LOS ANGELES CA 90024
K102654 VERTEX-DENTAL B.V. 22 RIVER ROAD
CLAREMONT NH 03743
K102640 VERTEX-DENTAL B.V. 220 RIVER ROAD
CLAREMONT NH 03743
K123220 VERTEX-DENTAL B.V. 154 MAIN ST.
CHARLESTOWN NH 03603
K191497 Vertex-Dental BV Centurionbaan 190
Soesterberg 3769 AV
K162572 VERTEX-DENTAL BV JOHAN VAN OLDENBARNEVELTLAAN
ZEIST 3705 HJ
K962333 VIDENT 3150 EAST BIRCH ST.
BREA CA 92821
K191926 VITA Zanhnfabrik H. Rauter GmbH Co. Spitelgasse 3
Bad Sackingen D-79713
K220743 VOCO GmbH Anton-Flettner-Str. 1-3
Cuxhaven 27472
K102347 VOCO GMBH ANTON-FLETTNER-STRASSE 1-3
CUXHAVEN D-27472
K110440 VOCO GMBH ANTON-FLETTNER-STR. 1-3
CUXHAVEN 27472
K974772 VOCO GMBH 7527 WESTMORELAND AVE.
ST. LOUIS MO 63105
K993827 VOCO GMBH 4235 BEACONSFIELD
MONTREAL QC,H4A 2H4
K143486 VOCO GMBH ANTON-FLETTNER-STR 1-3
CUXHAVEN D-27472
K030916 VOCO GMBH ANTON-FLETTNER-STRASSE 1-3
CUXHAVEN D-27472
K220236 Voco GmbH Anton-Flettner-Str. 1-3
Cuxhaven 27472
K140146 WHIP MIX CORP. 361 FARMINGTON AVE
LOUISVILLE KY 40217
K151142 WIELAND DENTAL + TECHNIK GMBH & CO. KG Lindenstr.2
Pforzheim D-75175
K131036 YAMAHACHI DENTAL MANUFACTURING CO. 110 EASTGRANADA BLVD. SUITE 209
ORMOND BEACH FL 32176
K172683 Yamahachi Dental Mfg., Co. 54-1, Ochigara
Gamamori-City 443-0105
K140570 ZEST ANCHORS, LLC 12264 El Camino Real, Suite 400
San Diego CA 92130
K232691 Zirkonzahn Srl An der Ahr 7
Gais 39030




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