Product code NBL
- Device name
- Laser, Fluorescence Caries Detection
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.1745
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252464 | Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. | 2026-04-28 |
| K242103 | TRIOS Ready Tip | 3Shape TRIOS A/S | 2025-04-04 |
| K221275 | Qraycam PRO | AIOBIO Co., Ltd. | 2024-09-04 |
| K231722 | SmarTooth | Smartooth Co., Ltd. | 2024-05-01 |
| K223470 | C50 | Sopro | 2023-12-14 |
| K221249 | L1P-1F (TRIOS 5) | 3Shape TRIOS A/S | 2022-09-16 |
| K183471 | IC-WHCD100 (Inspire) | Good Doctors Co., Ltd. | 2020-07-02 |
| K171007 | Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | 2018-05-03 |
| K170822 | Electronic Caries Detector | Ortek Therapeutics, Inc. | 2017-09-11 |
| K150672 | VistaCam iX Proof | Durr Dental AG | 2016-01-27 |
| K121685 | SOPROCARE | Sopro | 2013-03-12 |
| K112139 | THE CANARY SYSTEM | Quantum Dental Technologies, Inc. | 2012-10-26 |
| K111423 | CS 1600 INTRAORAL CAMERA | Carestream Health, Inc. | 2012-03-02 |
| K111321 | REMOTE VIEW SOFTWARE | Cariescan , Ltd. | 2011-05-17 |
| K093705 | FUORECAM | Therapeutic Technologies, Inc. | 2010-04-23 |
| K092583 | SOPROLIFE | Sopro | 2010-01-13 |
| K090598 | CARIESCAN PRO | Cariescan , Ltd. | 2009-12-15 |
| K090169 | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE | Air Techniques, Inc. | 2009-08-18 |
| K063321 | D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 | Neks Technologies, Inc. | 2007-03-30 |
| K051909 | DIAGNODENT | Kavo America | 2005-10-21 |
| K042394 | DIAGNODENT PERIO TIP (ACCESSORY) | Kavo America Corporation | 2005-08-02 |
| K043156 | D-CARIE, MODEL N121-M1 | Neks Technologies, Inc. | 2005-04-28 |
| K040063 | INSPEKTOR PRO | Inspektor Dental Care BV | 2004-06-24 |
| DEN990002 | KAVO DIAGNODENT | Kavo America | 2000-02-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| E27668082030 | Primescan 2 | SIRONA Dental Systems GmbH | 2025-11-21 |
| E27668082450 | Primescan 2 | SIRONA Dental Systems GmbH | 2025-10-23 |
| E27668053651 | Primescan 2 Multiuse Sleeve | SIRONA Dental Systems GmbH | 2025-09-16 |
| E27668558402 | Primescan 2 | SIRONA Dental Systems GmbH | 2025-08-20 |
| 05902729754149 | TRIOS 5 | 3shape Trios A/S | 2025-06-16 |
| E27668020400 | Primescan 2 | SIRONA Dental Systems GmbH | 2025-05-16 |
| 05902729753906 | TRIOS Ready Tip | 3shape Trios A/S | 2025-05-06 |
| 06977585090143 | Fluorescence Mode | Carl Zeiss Meditec (Suzhou) Co., Ltd. | 2025-03-26 |
| 04262352350035 | DI Scan | Zetta25 AG | 2025-02-21 |
| EKAV101537000 | DIAGNOcam Vision Full HD | KaVo Dental GmbH | 2024-12-03 |
| 08800043200090 | AIOBIO | AIOBIO CO.,LTD | 2024-12-02 |
| 08809941490008 | Smartooth | Smartooth Co., Ltd. | 2024-07-22 |
| 08809941490084 | Smartooth | Smartooth Co., Ltd. | 2024-07-22 |
| 08809941490121 | Smartooth | Smartooth Co., Ltd. | 2024-07-22 |
| 03760278267587 | ACTEON | SOPRO | 2024-05-02 |
| EKAV101112130 | DIAGNOcam Vision Full HD | KaVo Dental GmbH | 2024-02-01 |
| EKAV101315000 | DIAGNOcam Vision Full HD | KaVo Dental GmbH | 2024-02-01 |
| 00858197004062 | Ortek Therapeutics, Inc. | ORTEK THERAPEUTICS, INC | 2022-12-21 |
| 05902729753753 | TRIOS | 3shape Trios A/S | 2022-09-26 |
| 05902729753661 | TRIOS | 3shape Trios A/S | 2022-09-26 |
| 05902729753746 | TRIOS | 3shape Trios A/S | 2022-09-26 |
| 05902729753678 | TRIOS | 3shape Trios A/S | 2022-09-26 |
| 05902729753685 | TRIOS | 3shape Trios A/S | 2022-09-26 |
| 05902729753722 | TRIOS 5 | 3shape Trios A/S | 2022-09-26 |
| 05902729753739 | TRIOS 5 | 3shape Trios A/S | 2022-09-26 |
| 05902729753760 | TRIOS | 3shape Trios A/S | 2022-09-26 |
| 05902729753777 | TRIOS | 3shape Trios A/S | 2022-09-26 |
| 08800025400135 | Inspire | GOOD DOCTORS CO., LTD. | 2020-11-13 |
| E247J25101 | CamX Triton HD Handpiece | DÜRR DENTAL SE | 2018-07-06 |
| D678G41000 | CamX Spectra Caries Detection Aid | AIR TECHNIQUES, INC. | 2016-09-15 |