FDA 510(k) Applications for Medical Device:
X-Ray, Tomography, Computed, Dental
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K210820 | Alliage S/A Industrias Medico Odontol≤gica |
Rod. Abrπo Assed, Km 53+450m | Recreio Anhanguera | 14097-500 | |
| K223816 | Alliage S/A Industrias Medico Odontol≤gica. |
Rod. Abrπo Assed, Km 53+450m | Recreio Anhanguera | 14097-500 | |
| 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 | |
| K214084 | CEFLA S.C. |
Via Selice Provinciale 23/A | Imola | 40026 | |
| K223794 | CEFLA S.C. |
Via Selice Provinciale 23/A | Imola | 40026 | |
| K161900 | CEFLA SC |
VIA SELICE PROVINCIALE 13/A | IMOLA | 40026 | |
| K242805 | Changzhou Finno Medical Technology Co., Ltd. |
First Floor East and Third Floor, Building 5 | Changzhou | 213000 | |
| K201382 | de Gotzen S.r.l. |
Via Roma, 45 | Olgiate Olona | 21057 | |
| K160166 | DE GOTZEN S.R.L. |
VIA ROMA, 45 | OLGIATE OLONA, | 21057 | |
| K231181 | Dentium Co., Ltd (ICT Branch) |
76, Changnyong-daero 256beon-gil, Yeongtong-gu, | Suwon-si | 16229 | |
| K200271 | Dentium Co., Ltd (ICT Branch) |
76, Changnyong-daero 256beon-gil, Yeongtong-gu | Suwon-Si | 16229 | |
| K200270 | Dentium Co., Ltd (ICT Branch) |
76, Changnyong-daero 256beon-gil, Yeongtong-gu | Suwon-Si | 16229 | |
| K201140 | Dentsply Sirona |
221 West Philadelphia Street, Suite 60W | York | PA | 17401 |
| K191616 | Dentsply Sirona |
221 West Philadelphia Street, Suite 60W | York | PA | 17401 |
| K232487 | Durr Dental SE |
H÷pfigheimer Str. 17 | Bietigheim-Bissingen | 74321 | |
| 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 |
| K213579 | FONA S.r.l |
Via G.Galilei 11 | Assago | 20057 | |
| K220392 | GENORAY Co., Ltd. |
#512, 560, Dunchon-daero, Jungwon-gu | Seongnam-si | 13230 | |
| 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 | |
| K212254 | HDX Will Corp. |
#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro | Cheongju-si | 28161 | |
| K211159 | HDX WILL Corp. |
#105,106,201,202,203,204,38,Osongsaengmyeong-4-ro | 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 |
| K201378 | J. Morita USA, INC. |
9 Mason | Irvine | CA | 92618 |
| K171012 | J.Morita USA, Inc. |
9 Mason | Irvine | CA | 92618 |
| K123332 | LK CONSULTING GROUP |
1515 E KATELLA AVE. UNIT 2115 | ANAHEIM | CA | 92805 |
| K222219 | MegaGen Implant CO., Ltd. |
45, Secheon-ro, 7-gil | Daegu | 42921 | |
| 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 | |
| K212303 | Osstem Implant Co., Ltd. |
2 Floor, B-dong, 51, Mayu-ro 238beon-gil | Siheung-si | 15079 | |
| K233806 | Osstem Implant Co., Ltd. |
2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, | 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 | |
| K230505 | Palodex Group OY |
Nahkelantie 160 | Tuusula | 04300 | |
| K241249 | Palodex Group Oy |
Nahkelantie 160 | Tuusula | 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 | |
| K230985 | Planmeca Oy |
Asentajankatu 6 | Helsinki | 00880 | |
| K143435 | PLANMED OY |
Sorvaajankatu 7 | Helsinki | 00880 | |
| K180918 | Planmed Oy |
Sorvaajankatu 7 | Helsinki | 00880 | |
| K213278 | 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 | |
| K222150 | PreXion Corporation |
1-14-1, Kandasuda-cho | Chiyoda-ku | 101-0041 | |
| K232166 | PreXion Corporation |
1-14-1, Kandasuda-cho | 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 | |
| K203784 | PreXion Corporation |
1-14-1 Kandasuda-cho | Chiyoda-ku | 101-0041 | |
| K221525 | PreXion Corporation |
1-14-1, Kandasuda-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 | |
| K213226 | RAY Co., Ltd |
332-7, Samsung 1-ro | Hwaseong-si | 18380 | |
| K182805 | RAY Co., Ltd |
332-7, Samsung 1-ro | Hwaseong-si | 18380 | |
| K192737 | RAY CO., Ltd |
332-7, Samsung 1-ro | Hwaseong-si | 18380 | |
| K232287 | Ray Co., Ltd. |
1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu | Yongin-si | 16882 | |
| K243903 | RAY Co., Ltd. |
1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu | Yongin-si | 16882 | |
| K230753 | Ray Co., Ltd. |
1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu | Yongin-si | 16882 | |
| 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 | |
| K222666 | Trident s.r.l |
Via Artigiani 4 | Castenedolo | 25014 | |
| 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 | |
| K201627 | Vatech Co., Ltd |
13, Samsung 1-ro 2-gil | Hwaseong-si | 18449 | |
| 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 | |
| K243088 | VATECH Co., Ltd |
13, Samsung 1-ro 2-gil | Hwaseong-si | 18449 | |
| K210329 | Vatech Co., Ltd |
13, Samsung 1-ro 2-gil | Hwaseong-si | 18449 | |
| K243081 | VATECH Co., Ltd |
13, Samsung 1-ro 2-gil | Hwaseong-si | 18449 | |
| K231796 | Vatech Co., Ltd |
13, Samsung 1-Ro 2-Gil | Hwaseong-si | 18449 | |
| K160882 | VATECH CO., LTD |
13, SAMSUNG 1-RO 2-GIL | HWASEONG-SI | 18449 | |
| K203797 | 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 | |
| K251642 | Yian Medical Technology (Haining) Co., Ltd. |
1st Floor Area 1, 2nd Floor Area 1, Building A, No. 2 | Haining, Jiaxing | 314400 | |
| K240855 | Yian Medical Technology (Haining) Co., Ltd. |
1st Floor Area 1, 2nd Floor Area 1, Building A, | Haining, Jiaxing | 314400 | |
| K232710 | Yian Medical Technology (Haining) Co., Ltd. |
1st Floor Area 1, 2nd Floor Area 1, Building A, | Jiaxing | 314400 | |
| K243337 | Yofo Medical Technology Co., Ltd. |
Building A1, National Health Industrial Park, | Hefei | 230000 |
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