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 |
| K242103 | 3Shape TRIOS A/S | TRIOS Ready Tip | 04/04/2025 |
| K221275 | Aiobio Co., Ltd. | Qraycam PRO | 09/04/2024 |
| 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 |
| K231722 | Smartooth Co., Ltd. | SmarTooth | 05/01/2024 |
| K223470 | SOPRO | C50 | 12/14/2023 |
| K121685 | SOPRO | SOPROCARE | 03/12/2013 |
| K092583 | SOPRO | SOPROLIFE | 01/13/2010 |
| K093705 | THERAPEUTIC TECHNOLOGIES, INC. | FUORECAM | 04/23/2010 |
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