FDA 510(k) Applications for Medical Device:
System,X-Ray,Extraoral Source,Digital

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K131442 3DISC AMERICAS 8870 RAVELLO CT
NAPLES FL 34114
K041120 AFP IMAGING CORP. 250 CLEARBROOK RD.
ELMSFORD NY 10523
K123419 AFP IMAGING CORP. 8870 RAVELLO CT.
NAPLES FL 34114
K072357 AFP IMAGING CORP. 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K021542 AGFA CORP. 10 SOUTH ACADEMY ST.
GREENVILLE SC 29602-9048
K050693 AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD.
HICKSVILLE NY 11801
K013893 AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD.
HICKSVILLE NY 11801
K191623 Air Techniques, Inc. 1295 Walt Whitman Road
Melville NY 11747
K230732 Alliage S/A Industrias Medica Odontol≤gico. Rod. Abrπo Assed, Km 53+450m
Recreio Anhanguera 49935
K120106 APIXIA INC. 18688 SAN JOSE AVE.
INDUSTRY CA 91748
K211688 Athlos Oy Klovinpellontie 1-3, Tower 2
Espoo 02180
K031801 BLUE X IMAGING SRL 251 E. DUNDEE RD.
WHEELING IL 60090
K010915 CAMSIGHT CO., INC. 1530 BEACH ST.
MONTEBELLO CA 90640
K053221 CAMSIGHT CO., INC. 3380 SAN FERNANDO ROAD
LOS ANGELES CA 90065
K111649 CARESTREAM HEALTH, INC. 1765 THE EXCHANGE
ATLANTA GA 30339
K101661 CEFLA DENTAL GROUP 49 PLAIN STREET
NORTH ATTLEBORO MA 02760
K100960 CEFLA DENTAL GROUP 49 PLAIN STREET
NORTH ATTLEBORO MA 02760
K081088 CEFLA S.C. 110 E. GRANADA BLVD.
ORMOND BEACH FL 32176
K152162 CEFLA S.C. VIA SELICE PROVINCIALE 23/A
IMOLA 40026
K113497 CEFLA S.C. CEFLA DENTAL GROUP VIA BICOCCA N.14/C
IMOLA B040026
K061114 CEFLA S.C.R.L. 110 E GRANADA BLVD.
ORMOND BEACH FL 32176
K033147 CLEARTOOTH ELECTRONICS, INC. 3722 AVE. SAUSALITO
IRVINE CA 92606
K042736 CNC IMAGING, INC. 1559 EDEN COURT
SAN ELIJO HILLS CA 92078
K190234 CND Global Technologies, Inc. 16 Branch Avenue
Cumberland RI 02864
K183637 Cruxell Corp. A-405, Migun Techno World II 187 techno 2-ro, Yuseong-gu
Daejeon 34025
K211317 CRUXELL Corp. 405, Migun techno World II, 187, Techno 2-ro Yuseong-gu
Daejeon 34025
K203374 de G÷tzen S.r.l. Via Roma, 45
Olgiate Olona 21057
K191719 de Gotzen S.R.L via Roma, 45
Olgiate Olona 21057
K990087 DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. 16722 MILLIKAN AVE.
IRVINE CA 92606
K231202 Denterprise International Inc. 156 E Granada Blvd
Ormond Beach FL 32176
K151926 DENTERPRISE INTERNATIONAL, INC. 100 EAST GRANADA BLVD
ORMOND BEACH FL 32176
K092547 DENTIMAX 6965 EL CAMINO REAL
CARLSBAD CA 92009
K220556 DentiMax, Inc 4115 E Valley Auto Dr, Suite 101
Mesa AZ 85298
K153144 DENTTIO, INC. 3235 N. SAN FERNANDO ROAD BLDG 7B
LOS ANGELES CA 90065
K070811 DEXCO 11 DELLCASTLE COURT
MONTGOMERY VILLAGE MD 20886
K083532 DEXCOWIN CO., LTD #708 LE-MEILLEUR TOWN
SEOUL 135-937
K134055 DEXCOWIN CO., LTD 110 EAST GRANADA BLVD.
ORMOND BEACH FL 32176
K133007 DEXCOWIN CO., LTD 110 EAST GRANADA BLVD.
ORMOND BEACH FL 32176
K173046 Dexcowin Co., Ltd. #905, 2,, Gasan Digital 1-ro, GeumCheon-Gu
Seoul 08591
K090458 DEXIS LLC 1717 WEST COLLINS
ORANGE CA 92867
K990049 DIGIDENT LTD. 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K202633 Dⁿrr Dental SE H÷pfigheimer Str. 17
Bietigheim-Bissingen 74321
K013271 DOUGLAS C. YOON, DDS 3940 LAUREL CANYON BLVD. #147
STUDIO CITY CA 91604
K170733 Duerr Dental AG Hopfigheimer Strasse 17
Bietigheim-Bissingen D-74321
K230095 Durr Dental SE Hopfigheimer Str. 17
Bietigheim-Bissingen 74321
K203116 Durr Dental SE Hopfigheimer Str. 17
Bietigheim-Bissingen D-74321
K090526 E-WOO TECHNOLOGY 256 NORTH SAM HOUSTON PKWY E.
HOUSTON TX 77060
K060079 EASTMAN KODAK COMPANY 343 STATE ST.
ROCHESTER NY 14650
K103290 EDLEN IMAGING LLC 3707 N 7TH STREET
PHOENIX AZ 85014
K150823 EDLEN IMAGING LLC 16441 NORTH 91ST STREET
SCOTTSDALE AZ 85250
K020588 ESCAPE TECHNOLOGY, INC. 1530 BEACH ST.
MONTEBELLO CA 90640
K212103 FONA S.r.l Via G.Galilei 11
Assago 20057
K161131 FONA SRL VIA GALILEO GALILEI 11
ASSAGO 20090
K192766 Fsusen Technology Co., Ltd 1F, 3# Building, Tongfuyu Industrial Zone, Taoyuan Street,
Shenzhen 518055
K060178 GENDEX DENTAL SYSTEMS PO BOX 7007
DEERFIELD IL 60015
K232158 Genoray Co., Ltd. #512, 560, Dunchon-daero, Jungwon-gu
Seongnam-si 13230
K220423 GENORAY Co., Ltd. 512, 560, Dunchon-daero, Jungwon-gu
Seongnam-si 13230
K130419 GENORAY CO., LTD. 1073 N. Batavia St
Orange CA 92867
K141700 GENORAY CO., LTD. 3002 DOW AVENUE, SUITE 420
TUSTIN CA 92780
K130088 GENORAY CO., LTD. 1073 N, BATAVIA ST
ORANGE CA 92867
K120263 GENORAY CO., LTD. 1073 N. Batavia St
Orange CA 92867
K092171 GENORAY CO., LTD. 1073 N, BATAVIA ST
ORANGE CA 92867
K212080 Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin National High-Tech Zone
Guilin City 541004
K181297 HDX WILL CORP. #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro,
Cheongju-si 28161
K214091 Hefei DentaFilm Medical Equipment Co., Ltd No. 98 Tangkou Road,
Hefei 230601
K041580 HENRY SCHEIN, INC. 11661 SAN VICENTE BOULEVARD
LOS ANGELES CA 90049
K033248 HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK
TWINSBURG OH 44087
K061284 IMAGING SCIENCES INTL., INC. 1910 NORTH PENN RD.
HATFIELD PA 19440
K992392 INFIMED, INC. 121 METROPOLITAN DR.
LIVERPOOL NY 13088
K001439 INSTRUMENTARIUM CORP. 300 WEST EDGERTON AVE.
MILWAUKEE WI 53207
K992385 INSTRUMENTARIUM CORP. 300 WEST EDGERTON AVE.
MILWAUKEE WI 53207
K133231 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160
TUUSULA, FINLAND 04300
K092591 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160
TUUSULA, FINLAND 04300
K093683 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160
TUUSULA, FINLAND 04300
K063837 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160
TUUSULA, FINLAND 04300
K081925 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160
TUUSULA, FINLAND 04300
K001928 INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE.
MILWAUKEE WI 53207-6025
K230811 iRay Imaging Technology (Haining) Limited No. 2, Caohejing RD., Haining 314499, Jiaxing
Haining 314499
K220422 iRay Technology Taicang Ltd. No.33 Xinggang Rd., Taicang Port Economic & Technological
Taicang 215434
K212279 iRay Technology Taicang Ltd. No. 33 Xinggang Rd. Taicang Port Economic & Technological
Taicang 215434
K210312 iRay Technology Taicang Ltd. No.33 Xinggang Rd., Taicang Port Economic &
Ticang 215434
K053220 J. MORITA USA, INC. 1425 K ST. N.W.
WASHINGTON DC 20005
K073696 J. MORITA USA, INC. 1425 K ST. N.W.
WASHINGTON DC 20005
K163224 Jazz Imaging LLC 800 Charcot Avenue, Suite 100
San Jose CA 95131
K213637 Jazz Imaging LLC dba JAZZ Imaging
San Jose CA 95131
K990002 JULIE ALLIANCE 1095 MASON AVE.
DAYTONA BEACH FL 32117
K172918 KaVo Dental Technologies, LLC 11727 Fruehauf Drive
Charlotte NC 28273
K023292 KRUGMAN TECHNOLOGIES, INC 1000 HART RD.
BARRINGTON IL 60010
K163282 Masterlink LLC 24654 N. Lake Pleasant Parkway Suite 103-501
Peoria AZ 85383
K122806 MIC INTERNATIONAL 4-1-17 HONGO
TOKYO 113-0033
K091866 MIDMARK 675 HEATHROW DR.
LINCOLNSHIRE IL 60069
K112380 MIDMARK CORP. 675 HEATHROW DRIVE
LINCOLNSHIRE IL 60069
K122643 MIDMARK CORP. 675 HEATHROW DRIVE
LINCOLNSHIRE IL 60069
K002425 MULTI MEDIA DENTAL SYSTEMS, INC. 1302 MACY DR.
ROSWELL GA 30076
K143703 NICAL SPA VIA SOFFREDINI, 43
MILAN 20126
K983267 ORION CORPORATION SOREDEX NILSIANKATU 10-14
HELSINKI FIN-00510
K083057 OWANDY 110 E. GRANADA BLVD.
ORMOND BEACH FL 32176
K062403 OWANDY 110 E. GRANADA BLVD.
ORMOND BEACH FL 32176
K070505 OWANDY 110 EAST GRANADA BLVD
ORMOND BEACH FL 32176
K133271 OWANDY 110 EAST GRANADA BLVD, SUITE 207
ORMOND BEACH FL 32176
K053172 OWANDY SAS 1251 AVENUE OF THE AMERICAS
NEW YORK NY 10020
K051664 OY AJAT, LTD. 110 E GRANADA BLVD. SUITE 207
ORMOND BEACH FL 32176
K173646 PaloDEx Group Oy Nahkelantie 160
Tuusula 04300
K141130 PANORAMIC CORP. 8870 RAVELLO CT
NAPLES FL 34114
K110371 PANORAMIC CORP. 8870 RAVELLO CT
NAPLES FL 34114
K000454 PLANMECA OY 362 BALM COURT
WOOD DALE IL 60191-1273
K060328 PLANMECA OY ASENTAJANKATU 6
HELSINKI FI-00880
K093590 PLANMECA OY ASENTAJANKATU 6
HELSINKI 00880
K103689 PLANMECA OY ASENTAJANKATU 6
HELSINKI FI-00880
K072244 PLANMECA OY ASENTAJANKATU 6
HELSINKI 00880
K121800 POINTNIX CO., LTD 55 NORTHERN BLVD
GREAT NECK NY 11021
K070664 PROGENY, INC. 1407 BARCLAY BLVD.
BUFFALO GROVE IL 60089
K041831 PROGENY, INC. 1407 BARCLAY BLVD.
BUFFALO GROVE IL 60089
K232255 Qpix Solutions Inc. 1001 Aviation Parkway, Ste 200
Morrisville NC 27560
K131693 RAY CO., LTD 4747 HOEN AVE.
SANTA ROSA CA 95405
K142058 RAY CO., LTD 4747 HOEN AVE.
SANTA ROSA CA 95405
K122918 RAY CO., LTD 8920 WILSHIRE BLLVD
BEVERLY HILLS CA 90211
K160788 RAY CO., Ltd 332-7, Samsung 1-ro
Hwaseong-si 445-330
K153060 RAYENCE CO., LTD 14, SAMSUNG 1-RO, 1-GIL
HWASEONG-SI 445-170
K150797 Rayence Co., Ltd 14, Samsung 1-ro, 1-gil
Hwaseong-si 445-170
K143753 Rayence Co., Ltd 14, Samsung 1-ro, 1-gil
Hwaseong-si 445-170
K151707 RAYENCE CO., LTD 14, SAMSUNG 1-RO, 1-GIL
HWASEONG-SI 445-170
K221955 RealCloud Imaging Inc. dba RealCloud Imaging 2625 North Loop Drive, Suite 2130
Ames IA 50010
K200284 Remedi Co. Ltd. #1409, IS BIZ Tower, 26 Yangpyeong-ro 21
Seoul
K111103 RF CO., LTD 6-5-3 BEAUNE HONKOMAGOME 2F
BUNKYO-KU, TOKYO 113-0021
K202369 Rolence Enterprise Inc. 18-3 Lane 231 Pu Chung Rd., Chungli
Taoyuan 32083
K031291 SCHICK TECHNOLOGIES, INC. 30-00 47TH AVE.
LONG ISLAND CITY NY 11101
K053558 SCHICK TECHNOLOGIES, INC. 30-00 47TH AVE., FIFTH FLOOR
LONG ISLAND CITY NY 11101
K110768 SCHICK TECHNOLOGIES, INC. 30-30 47TH AVE.
LONG ISLAND CITY NY 11101
K022953 SCHICK TECHNOLOGIES, INC. 30-00 47TH AVE.
LONG ISLAND CITY NY 11101
K072134 SCHICK TECHNOLOGIES, INC. 30-30 47TH AVE.
LONG ISLAND CITY NY 11101
K221008 Shanghai Handy Medical Equipment Co., Ltd Floor 2, Building No. 11, Lane177, Fulian Er Road
Baoshan District 201906
K220277 Shenzhen Xpectvision Technology Co.,Ltd. B507,Block A and B,Nanshan Medical Device Industrial Park,
Shenzhen 518067
K060179 SIGMA BIOMEDICS, INC. 65 E. PALATINE RD.
PROSPECT HEIGHTS IL 60070
K983283 SIGNET RADIOLOGY, INC. 253 LOGUE RD
MINTO, NB EOE 1JO
K060892 SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31
BENSHEIM D-64625
K013659 SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST.
NORTH ATTLEBORO MA 02760-4153
K990528 SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST.
NORTH ATTLEBORO MA 02760-4153
K983057 SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST.
NORTH ATTLEBORO MA 02760-4153
K013650 SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST.
NORTH ATTLEBORO MA 02760-4153
K992644 SIRONA DENTAL SYSTEMS GMBH 49 PLAIN ST.
NORTH ATTLEBORO MA 02760-4153
K081903 SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31
BENSHEIM D-64625
K181636 Sodium Systems, LLC 1050 Highland Drive, Suite E
Ann Arbor MI 48108
K024186 SOMETECH CORPORATION 6669 PEACHTREE INDUSTRIAL BLVD
NORCROSS GA 30092
K092329 SOPRO 124 GAITHER DRIVE
MT. LAUREL NJ 08054
K151053 SOPRO - ACTEON GROUP ZAC ATHELIA IV AVENUE DES GENEVRIERS
LA CIOTAT 13705
K142995 SOPRO - ACTEON GROUP
LaCiotat 13705
K140013 SOPRO - ACTEON GROUP 124 GAITHER DRIVE SUITE #140
MT. LAUREL NJ 08055
K063459 SOREDEX PALODEX GROUP OY NAHKELANTIE 160
TUUSULA 00430
K041050 SOREDEX PALODEX GROUP OY ELIMAENKATU 22 B
HELSINKI
K012170 SOREDEX PALODEX GROUP OY NILSIANATU 10-14
HELSINKI FIN 00510
K070304 SOREDEX PALODEX GROUP OY NAHKELANTIE 160
TUUSULA FIN-04300
K073350 SOREDEX PALODEX GROUP OY NAHKELANTIE 160
TUUSULA FIN-04300
K202664 Sota Precision Optics, Inc. dba SOTA Imaging 1073 North Batavia Street, Suite B
Orange CA 92867
K021718 SUNI IMAGING MICROSYSTEMS, INC. 6840 VIA DEL ORO, SUITE 10
SAN JOSE CA 95119
K162585 Suni Medical Imaging, Inc 6840 Via Del Oro Suite 160
San Jose CA 95119
K060149 SUNI MEDICAL IMAGING, INC. 6840 VIA DEL ORO, SUITE 160
SAN JOSE CA 95119
K070219 SUNI MEDICAL IMAGING, INC. 38 MILLER AVE, PMB 170
MILL VALLEY CA 94941
K110160 TAKARA BELMONT CORPORATION 101 BELMONT DR
SOMERSET NJ 08873
K163175 Takara Belmont Corporation 1-1-2 Chome, Higashi-Shinsaibashi, Chuo-ku
Osaka 542-0083
K041834 TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE
WEST CALDWELL NJ 07006
K062529 TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE
WEST CALDWELL NJ 07006
K102456 TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE
WEST CALDWELL NJ 07006
K090020 TAKARA-BELMONT CO., LTD. 101 BELMONT DRIVE
SOMERSET NJ 08873-1204
K181358 Televere Systems, Inc. 1160 Cavalier Road
Arnold MD 21012
K111231 THE YOSHIDA DENTAL MFG. CO., LTD. 4-1-17 HONGO, BUNKYO-KU
TOKYO 113-0033
K182198 The Yoshida Dental Mfg. Co., Ltd. 1-3-6, Kotobashi
Sumida-ku 130-8516
K092537 TOSHIBA AMERICA ELECTRONIC COMPONENTS, INC. 2150 EAST LAKE COOK RD.,
BUFFALO GROVE IL 60089
K200625 Trident s.r.l Via Artigiani 4
Castenedolo 25014
K160386 TRIDENT S.R.L VIA VERDI 20
ASSAGO 20090
K162619 TRIDENT S.R.L. VIA VERDI 20
ASSAGO 20090
K120975 TROPHY 4 RUE F. PELLOUTIER CROISSY
MARNE LA VALLEE CEDEX 2 77437
K151087 TROPHY 4 RUE F. PELLOUTIER
CROISSY-BEAUBOURG 77435
K073435 TROPHY 4 RUE F. PELLOUTIER CROISSY
MARNE LA VALLEE CEDEX 2 77437
K080889 TROPHY 4 RUE F. PELLOUTIER
CROISSY-BEAUBOURG 77435
K082972 TROPHY 4 RUE F. PELLOUTIER CROISSY
MARNE LA VALLEE CEDEX 2 77437
K093478 TROPHY 4 RUE F. PELLOUTIER
CROISSY-BEAUBOURG 77435
K012514 TROPHY RADIOLOGIE 4 RUE F. PELLOUTIER
MARNE LA VALLEE CEDEX 2 77437
K023346 TROPHY RADIOLOGIE 4 RUE F. PELLOUTIER
MARNE LA VALLEE CEDEX 2 77437
K170731 Vatech Co., Ltd 13, Samsung 1-ro 2-gil
Hwaseong-si 445-170
K102124 VATECH CO., LTD. 333 MEADOWLANDS PARKWAY,
SECAUCUS NJ 07094
K073365 VATECH CO., LTD. 30 NORTHPORT ROAD
SOUND BEACH NY 11789
K100317 VATECH CO., LTD. 256 NORTH SAM HOUSTON PKWY E.
HOUSTON TX 77060
K113672 VATECH CO., LTD. 12946 KIMBERLEY LN
HOUSTON TX 77079
K122155 VATECH CO., LTD. 12946 KIMBERLEY LN
HOUSTON TX 77079
K130585 VATECH CO., LTD. 12946 KIMBERLEY LN
HOUSTON TX 77079
K042372 VATECH VALUE ADDED TECHNOLOGY CO., LTD P.O. BOX 7007
DEERFIELD IL 60015
K070535 VIDEO DENTAL CONCEPTS, INC. 110 E. GRANADA BLVD., STE. 207
ORMOND BEACH FL 32175
K111152 VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3
BUCCINASCO 20090
K162190 VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3
BUCCINASCO I-20090
K120318 VIVI S.R.L. VIA BORGO SANTA
IMOLA 40026
K993958 X-CEL X-RAY CORP. 4220 WALLER DR., P.O. BOX 1857
CRYSTAL LAKE IL 60039-1857
K133206 ZUMA DENTAL, LLC 27001 LA PAZ ROAD, STE 312
MISSION VIEJO CA 92691




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