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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