FDA 510(k) Applications for Medical Device Product Code "NBL"
(Laser,Fluorescence Caries Detection)

FDA 510(k) Number Applicant Device Name Decision Date
K221249 3Shape TRIOS A/S L1P-1F (TRIOS 5) 09/16/2022
K090169 AIR TECHNIQUES, INC. SPECTRA FLUORESCENCE CARIES DETECTION DEVICE 08/18/2009
K111423 CARESTREAM HEALTH,INC. CS 1600 INTRAORAL CAMERA 03/02/2012
K090598 CARIESCAN LTD. CARIESCAN PRO 12/15/2009
K111321 CARIESCAN LTD. REMOTE VIEW SOFTWARE 05/17/2011
K171007 Carl Zeiss Suzhou Co., Ltd. Fluorescence Mode 05/03/2018
K150672 Durr Dental AG VistaCam iX Proof 01/27/2016
K183471 Good Doctors Co.,Ltd. IC-WHCD100 (Inspire) 07/02/2020
K040063 INSPEKTOR DENTAL CARE BV INSPEKTOR PRO 06/24/2004
K051909 KAVO AMERICA DIAGNODENT 10/21/2005
DEN990002 KAVO AMERICA KAVO DIAGNODENT 02/22/2000
K042394 KAVO AMERICA CORPORATION DIAGNODENT PERIO TIP (ACCESSORY) 08/02/2005
K043156 NEKS TECHNOLOGIES, INC. D-CARIE, MODEL N121-M1 04/28/2005
K063321 NEKS TECHNOLOGIES, INC. D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 03/30/2007
K170822 Ortek Therapeutics, Inc. Electronic Caries Detector 09/11/2017
K112139 QUANTUM DENTAL TECHNOLOGIES INC THE CANARY SYSTEM 10/26/2012
K121685 SOPRO SOPROCARE 03/12/2013
K092583 SOPRO SOPROLIFE 01/13/2010
K093705 THERAPEUTIC TECHNOLOGIES, INC. FUORECAM 04/23/2010


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