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
K203836 ChangZhou BoMedent Medical Technology Co., Ltd No.9 Changyang Road,
Changzhou 213100
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
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




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