FDA 510(k) Applications for Medical Device:
Laser,Fluorescence Caries Detection

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K221249 3Shape TRIOS A/S Holmens Kanal 7
Copenhagen K Dk-1060
K090169 AIR TECHNIQUES, INC. 55 Northern Blvd
Great Neck NY 11021
K111423 CARESTREAM HEALTH,INC. 1765 THE EXCHANGE
ATLANTA GA 30339
K090598 CARIESCAN LTD. PROSPECT BUSINESS CENTRE
DUNDEE DD2 1SW
K111321 CARIESCAN LTD. UNIT 5 GATEWAY WEST,
DUNDEE, ANGUS DD2 1XZ
K171007 Carl Zeiss Suzhou Co., Ltd. Modern Industrial Square 3b
Suzhou 215126
K150672 Durr Dental AG Hopfigheimer Strasse 17
Bietigheim-Bissingen D-74321
K183471 Good Doctors Co.,Ltd. #208, B-Dong, 283 Bupyeong-Daero, Bupyeong-Gu
Incheon 21315
K040063 INSPEKTOR DENTAL CARE BV QUELLINJNSTRAAT 92
AMSTERDAM 1072 XX
K051909 KAVO AMERICA PO BOX 7007
DEER FIELD IL 60015
DEN990002 KAVO AMERICA 340 EAST MAIN ST.
LAKE ZURICH IL 60047
K042394 KAVO AMERICA CORPORATION PO BOX 7007
DEERFIELD IL 60015
K043156 NEKS TECHNOLOGIES, INC. 208 BARRINGTON OVERLOOK DRIVE
DURHAM NC 27703
K063321 NEKS TECHNOLOGIES, INC. 2816, JOSEPH A. BOMBARDIER
LAVAL, QUEBEC H7P 6E2
K170822 Ortek Therapeutics, Inc. 4 Expressway Plaza
Roslyn Heights NY 11577
K112139 QUANTUM DENTAL TECHNOLOGIES INC 748 BRIAR HILL AVENUE
TORONTO, ONTARIO M6B 1L3
K121685 SOPRO 124 GAITHER DRIVE
MT. LAUREL NJ 08054
K092583 SOPRO 124 GAITHER DRIVE
MT. LAUREL NJ 08054
K093705 THERAPEUTIC TECHNOLOGIES, INC. 351 W.10TH ST., STE. 222
INDIANAPOLIS IN 46202-4119




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