FDA 510(k) Applications for Medical Device:
Locator, Root Apex
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K955088 | AMERICAN MEDICAL & DENTAL CORP. |
1236 BRACE RD. | CHERRY HILL | NJ | 08034 |
| K030895 | ASEPTICO, INC. |
8333 216TH ST., S.E. | WOODINVILLE | WA | 98072 |
| K231990 | Cefla S.C. |
Via Selice Provinciale N.23/A | Imola | 40026 | |
| K203836 | ChangZhou BoMedent Medical Technology Co., Ltd |
No.9 Changyang Road, | Changzhou | 213100 | |
| K232717 | Changzhou Haili Medical Co., Ltd. |
Hutang Science Technology Industrial Park, | Changzhou | 213000 | |
| K992233 | DENT CORP. RESEARCH & DEVELOPMENT |
7-11 S.BROADWAY | WHITE PLAINS | NY | 10601 |
| K131907 | DENTSPLY INTERNATIONAL INC. |
221 WEST PHILADELPHIA ST. | YORK | PA | 17401 |
| K191806 | Dentsply Sirona |
221 West Philadelphia Street | York | PA | 17401 |
| K111474 | FORUM ENGINEERING TECHNOLOGIES (96) LTD. |
1 PLATIN ST. | RISHON LEZION | 75653 | |
| K121206 | FORUM ENGINEERING TECHNOLOGIES LTD |
1 PLATIN ST, NEW INDUSTRIAL ZONE | RISHON LEZION | 75653 | |
| K212178 | Foshan COXO Medical Instrument Co., Ltd. |
BLDG 4, District A, Guangdong New Light Source | Foshan | 528226 | |
| K151274 | GOOD DOCTORS CO., LTD. |
#208, Woolim Lions Valley B-dong, 283 Bupyeong-daero | Incheon | 403-911 | |
| K171867 | Good Doctors Co.,Ltd. |
#208, B-Dong, 283 Bupyeong-Daero, Bupyeong-Gu | Incheon | 21315 | |
| K181087 | Guilin Woodpecker Medical Instrument Co., Ltd. |
Information Industrial Park, Guilin National High-Tech Zone | Guilin City | 541004 | |
| K022147 | J. MORITA USA, INC. |
601 13TH STREET, N.W. | WASHINGTON | DC | 20005 |
| K090925 | J. MORITA USA, INC. |
1425 K STREET NW | WASHINGTON | DC | 20005 |
| K962853 | L.S. SCIENTIFIC |
41 POLK ST. | RIVERSIDE | NJ | 08075 |
| K032743 | MEDIC NRG LTD. |
POB 367 | RAMAT HASHARON | 47103 | |
| K080113 | MEDICNRG LTD. |
291 HILLSIDE AVE. | SOMERSET | MA | 02726 |
| K101177 | MEDICNRG LTD. |
291 HILLSIDE AVE. | SOMERSET | MA | 02726 |
| K063843 | MEDICNRG LTD. |
291 HILLSIDE AVE. | SOMERSET | MA | 02726 |
| K071133 | MEDICNRG LTD. |
291 HILLSIDE AVE. | SOMERSET | MA | 02726 |
| K053235 | MEDICSENSE U.S.A. |
291 Hillside Avenue | Somerset | MA | 02726 |
| K210789 | Meta Systems Co., Ltd. |
#1214-18, Sicox tower 12F, 484, Dunchon-daero, Jungwon-gu | Seongnam-si | 13229 | |
| K103123 | MICRO-MEGA SOCIETE ANONYME |
5-12 RUE DU TUNNEL | CEDEX BESANCON | 25006 | |
| K002195 | PARKELL, INC. |
155 SCHMITT BLVD. | FARMINGDALE | NY | 11735 |
| K101054 | ROMIDAN LTD |
5 SIMCHA HOLZBERG ST. | KIRYAT-ONO | 55022 | |
| K100450 | S-DENTI CO., LTD. |
505-14, GASAN-DONG | SEONGNAM-CITY, SEOUL | 153-803 | |
| K112508 | S-DENTI CO., LTD. |
VALLEY 6,481-4 | TAE KYE NAM | 153-803 | |
| K112153 | S-DENTI CO., LTD. |
300 ATWOOD | PITTSBURGH | PA | 15213 |
| K083901 | S-DENTI CO., LTD. |
5401 S COTTONWOOD CT | GREENWOOD VILLAGE | CO | 80121 |
| K242383 | Shenzhen Rogin Medical Co., Ltd. |
Room 3109, Block 6, Tian'an Cloud Park | Shenzhen | 518129 | |
| K242765 | Shenzhen Superline Technology Co., Ltd. |
Room 302, Nanshan Zhiyuan A4, No.1001 Xueyuan Avenue, | Shenzhen | 518000 | |
| K962803 | SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K073185 | TECHDENT TECHNOLOGIES, LTD. |
MIZPE AVIV, INDUSTRIAL PARK 13 | M.P. MISGAV | 20187 | |
| K022020 | TOEI ELECTRIC CO., LTD. |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K972407 | TOEI ELECTRIC CO., LTD. |
1300 I STREET, N.W. | WASHINGTON | DC | 20005 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
