FDA 510(k) Applications for Medical Device:
X-Ray, Tomography, Computed, Dental

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K041137 APERIO SERVICES, LLC 950 S. TAMIAMI TRAIL,
SARASOTA FL 34236
K003787 APERIO SERVICES, LLC 815 CONNECTICUT AVENUE, NW
WASHINGTON, DC 20006-4078
K200688 CEFLA S.C. Via Selice Provinciale 23/A
Imola 40026
K123381 CEFLA S.C. 110 E. GRANADA BLVD.
ORMOND BEACH FL 32176
K190496 CEFLA S.C. Via Selice Provinciale 23/A
Imola 40026
K161900 CEFLA SC VIA SELICE PROVINCIALE 13/A
IMOLA 40026
K160166 DE GOTZEN S.R.L. VIA ROMA, 45
OLGIATE OLONA, 21057
K201140 Dentsply Sirona 221 West Philadelphia Street, Suite 60W
York PA 17401
K191616 Dentsply Sirona 221 West Philadelphia Street, Suite 60W
York PA 17401
K193139 Durr Dental SE Hopfigheimer Str. 17
Bietigheim-Bissingen 74321
K181432 Durr Dental SE Hopfigheimer Strasse 17
Bietigheim-Bissingen D-74321
K090171 E-WOO TECHNOLOGY 256 NORTH SAM HOUSTON PKWY E.
HOUSTON TX 77060
K082410 E-WOO TECHNOLOGY 340 SHADY GROVE ROAD
FLINTVILLE TN 37335
K151137 EDLEN IMAGING LLC 16441 NORTH 91ST STREET
SCOTTSDALE AZ 85260
K190856 Epica International Inc. 2753 Camino Capistrano. Suite A-101
San Clemente CA 92672
K150354 GENORAY CO., LTD. 512 BYUCKSAN TECHNOPIA 434-6
SEONGNAM-CITY 462-716
K200469 Genoray Co.,Ltd # 512, 560, Dunchon-daero, Jungwon-gu,
Seongnam-si 13230
K160140 HDX WILL CORP. #105, 201, 202, 203, 204, 38
Cheongju-si 28161
K120753 ICRCO INC. 2580 WEST 237TH STREET
TORRANCE CA 90505
K133620 IMAGING SCIENCES INTERNATIONAL 1910 NORTH PENN RD.
HATFIELD PA 19454
K162085 IMAGING SCIENCES INTERNATIONAL 1910 NORTH PENN RD.
HATFIELD PA 19454
K063773 INSTRUMENTARIUM DENTAL INC. 300 WEST EDGERTON AVE.
MILWAUKEE WI 53207-6025
K171012 J.Morita USA, Inc. 9 Mason
Irvine CA 92618
K123332 LK CONSULTING GROUP 1515 E KATELLA AVE. UNIT 2115
ANAHEIM CA 92805
K201667 Midmark Corporation 1001 Asbury Drive
Buffalo Grove IL 60089
K122606 MTECH GROUP 12946 KIMBERLEY LN
HOUSTON TX 77079
K183475 Osstem Implant Co., Ltd. 2 Floor, B-dong, 51, Mayu-ro 238beon-gil
Siheung-si 15079
K130443 OWANDY 110 E. GRANADA BLVD.
ORMOND BEACH FL 32176
K122018 PALODEX GROUP OY NAHKELANTIE 160
TUUSULA 04300
K133544 PALODEX GROUP OY NAHKELANTIE 160
TUUSULA 04300
K170813 PaloDEx Group Oy Nahkelantie 160
Tuusula 04300
K180947 PaloDEx Group Oy Nahkelantie 160
Tuusula 04300
K163423 PaloDEx Group Oy Nahkelantie 160
Tuusula FI-04300
K130297 PALODEX GROUP OY NAHKELANTIE 160
TUUSULA 04300
K152489 PANORAMIC CORP. 4321 Goshen Rd
FT. WAYNE IN 46818
K160506 PLANMECA OY ASENTAJANKATU 6
HELSINKI 00880
K181576 Planmeca Oy Asentajankatu 6
Helsinki 00880
K143435 PLANMED OY Sorvaajankatu 7
Helsinki 00880
K180918 Planmed Oy Sorvaajankatu 7
Helsinki 00880
K181983 PreXion Corporation 1-14-1 Kandasuda-cho
Chiyoda-ku 101-0041
K173878 PreXion Corporation 1-14-1 Kandasuda-cho
Chiyoda-ku 101-0041
K161881 PreXion Corporation Funai Tokyo Technology Center Building,
Chiyoda-ku 101-0041
K190320 PreXion Corporation 1-14-1, Kanda Suda-cho
Chiyoda-ku 101-0041
K193329 PreXion Corporation 1-14-1, Kanda Suda-cho
Chiyoda-ku 101-0041
K110260 QR S.R.L. VIA SILVESTRINI 20
VERONA, VR 37135
K130442 QR S.R.L. 110 E. GRANADA BLVD.
ORMOND BEACH FL 32176
K151612 QR S.r.l. Via Silvestrini 20
Verona 37135
K142247 RAY CO., LTD 332-7, SAMSUNG1-RO
HWASEONG-SI 445-330
K131695 RAY CO., LTD 4747 HOEN AVE.
SANTA ROSA CA 95405
K122981 RAY CO., LTD 8920 WILSHIRE BLVD
BEVERLY HILLS CA 90211
K190812 RAY Co., Ltd 332-7, Samsung 1-ro
Hwaseong-si 18380
K192737 RAY CO., Ltd 332-7, Samsung 1-ro
Hwaseong-si 18380
K182805 RAY Co., Ltd 332-7, Samsung 1-ro
Hwaseong-si 18380
K181452 Ray Co., Ltd. 332-7, Samsung 1-ro
Hwaseong-si 18380
K182614 RAY Co.,Ltd 332-7, Samsung 1-ro
Hwaseong-si 18380
K160525 RAY CO.,LTD 332-7, SAMSUNG 1-RO
HWASEONG-SI 445-330
K123070 SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31
BENSHEIM D-64625
K150217 Sirona Dental Systems GMBH Fabrikstrasse 31
Bensheim 64623
K103711 SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31
BENSHEIM 64625
K110839 SOREDEX PALODEX GROUP OY NAHKELANTIE 160
TUUSULA FIN-04300
K083917 SUNI MEDICAL IMAGING, INC. 6840 VIA DEL ORO
SAN JOSE CA 95119-1379
K101181 TAKARA BELMONT CORP. 8870 RAVELLO COURT
NAPLES FL 34114
K133797 TELESYSTEMS CO., LTD. 110 EAST GRANADA BLVD.
ORMOND BEACH FL 32176
K063622 THE YOSHIDA DENTAL MFG. CO., LTD. P.O. BOX 7007
DEERFIELD IL 60015
K120948 THE YOSHIDA DENTAL MFG. CO., LTD. 1-3-6 KOTOBASHI, SUMIDA-KU
TOKYO 130-8516
K122199 THE YOSHIDA DENTAL MFG. CO., LTD. 1-14-1 KANDASUDA-CHO
CHIYODA-KU, TOKYO 101-0041
K133406 TROPHY 4 RUE F. PELLOUTIER CROISSY
MARNE LA VALLEE CEDEX 2 77437
K103659 TROPHY 4 RUE F. PELLOUTIER CROISSY
MARNE LA VALLEE CEDEX 2 77437
K181136 Trophy 4 Rue F. Pelloutier
Croissy Beaubourg 77435
K200183 Trophy 4 Rue F. Pelloutier
Croissy Beaubourg 77435
K152106 VATECH CO., LTD 13, SAMSUNG 1-RO 2-GIL
HWASEONG-SI 445-170
K162660 VATECH CO., LTD 13, SAMSUNG 1-RO 2-GIL
HWASEONG-SI 445-170
K160882 VATECH CO., LTD 13, SAMSUNG 1-RO 2-GIL
HWASEONG-SI 18449
K102196 VATECH CO., LTD. 333 MEADOWLANDS PARKWAY
SECAUCUS NJ 07094
K090467 VATECH CO., LTD. 256 NORTH SAM HOUSTON PKWY E.
HOUSTON TX 77060
K170066 VATECH CO., LTD. 13, Samsung 1-ro 2-gil
Hwaseong-si 445-170
K082350 VATECH CO., LTD. 256 NORTH SAM HOUSTON PKWY E.
HOUSTON TX 77060
K121236 VATECH CO., LTD. 12946 KIMBERLEY LN
HOUSTON TX 77079
K121412 VATECH CO., LTD. 12946 KIMBERLEY LN
HOUSTON TX 77079
K121400 VATECH CO., LTD. 12946 KIMBERLEY LN
HOUSTON TX 77079
K130432 VATECH CO., LTD. 12946 KIMBERLEY LN
HOUSTON TX 77079
K132983 VATECH CO., LTD. 8310 BUFFALO SPEEDWAY
HOUSTON TX 77025
K180601 Villa Sistemi Medicali S.p.A. via delle Azalee 3
Buccinasco I-20090




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