Light-Induced Fluorescence Caries Detector
Regulation 872.1745
1510(k)s in 12 months (24 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NBL
| Company | 510(k)s | Recalls |
|---|---|---|
| Kavo America | 3 | 0 |
| Sopro | 3 | 0 |
| 3Shape TRIOS A/S | 2 | 0 |
| Cariescan , Ltd. | 2 | 0 |
| Neks Technologies, Inc. | 2 | 0 |
| AIOBIO Co., Ltd. | 1 | 0 |
| Air Techniques, Inc. | 1 | 0 |
| Carestream Health, Inc. | 1 | 0 |
| Carl Zeiss Suzhou Co., Ltd. | 1 | 0 |
| Durr Dental AG | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 28, 2026 | K252464 | Surgical Microscope (OMS2360, OMS2380) Zumax Medical Co., Ltd., CN | NBL |
| Apr 4, 2025 | K242103 | TRIOS Ready Tip 3Shape TRIOS A/S, DK | NBL |
| Sep 4, 2024 | K221275 | Qraycam PRO AIOBIO Co., Ltd., KR | NBL |
| May 1, 2024 | K231722 | SmarTooth Smartooth Co., Ltd., KR | NBL |
| Dec 14, 2023 | K223470 | C50 Sopro, FR | NBL |
| Sep 16, 2022 | K221249 | L1P-1F (TRIOS 5) 3Shape TRIOS A/S, DK | NBL |
| Jul 2, 2020 | K183471 | IC-WHCD100 (Inspire) Good Doctors Co., Ltd., KR | NBL |
| May 3, 2018 | K171007 | Fluorescence Mode Carl Zeiss Suzhou Co., Ltd., CN | NBL |
| Sep 11, 2017 | K170822 | Electronic Caries Detector Ortek Therapeutics, Inc. | NBL |
| Jan 27, 2016 | K150672 | VistaCam iX Proof Durr Dental AG, DE | NBL |
| Mar 12, 2013 | K121685 | SOPROCARE Sopro | NBL |
| Oct 26, 2012 | K112139 | THE CANARY SYSTEM Quantum Dental Technologies, Inc., CA | NBL |
| Mar 2, 2012 | K111423 | CS 1600 INTRAORAL CAMERA Carestream Health, Inc. | NBL |
| May 17, 2011 | K111321 | REMOTE VIEW SOFTWARE Cariescan , Ltd., GB | NBL |
| Apr 23, 2010 | K093705 | FUORECAM Therapeutic Technologies, Inc. | NBL |
| Jan 13, 2010 | K092583 | SOPROLIFE Sopro | NBL |
| Dec 15, 2009 | K090598 | CARIESCAN PRO Cariescan , Ltd., GB | NBL |
| Aug 18, 2009 | K090169 | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE Air Techniques, Inc. | NBL |
| Mar 30, 2007 | K063321 | D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 Neks Technologies, Inc., CA | NBL |
| Oct 21, 2005 | K051909 | DIAGNODENT Kavo America | NBL |
| Aug 2, 2005 | K042394 | DIAGNODENT PERIO TIP (ACCESSORY) Kavo America Corporation | NBL |
| Apr 28, 2005 | K043156 | D-CARIE, MODEL N121-M1 Neks Technologies, Inc. | NBL |
| Jun 24, 2004 | K040063 | INSPEKTOR PRO Inspektor Dental Care BV, NL | NBL |
| Feb 22, 2000 | DEN990002 | KAVO DIAGNODENT Kavo America | NBL |
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