Light-Induced Fluorescence Caries Detector
FDA product code NBL · Class II (moderate risk) · 21 CFR 872.1745 · Dental
23510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Sopro 3
- Neks Technologies, Inc. 2
- Kavo America 2
- Cariescan , Ltd. 2
- 3Shape TRIOS A/S 2
- Zumax Medical Co., Ltd. 1
- Inspektor Dental Care BV 1
- AIOBIO Co., Ltd. 1
- Smartooth Co., Ltd. 1
- Good Doctors Co., Ltd. 1
- Carl Zeiss Suzhou Co., Ltd. 1
- Ortek Therapeutics, Inc. 1
- Durr Dental SE 1
- Quantum Dental Technologies, Inc. 1
- Carestream Health, Inc. 1
- Therapeutic Technologies, Inc. 1
- Air Techniques, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252464 | Surgical Microscope (OMS2360, OMS2380)NBL · Traditional | Zumax Medical Co., Ltd. | 04/28/2026SE |
| K242103 | TRIOS Ready TipNBL · Traditional | 3Shape TRIOS A/S | 04/04/2025SE |
| K221275 | Qraycam PRONBL · Traditional | AIOBIO Co., Ltd. | 09/04/2024SE |
| K231722 | SmarToothNBL · Traditional | Smartooth Co., Ltd. | 05/01/2024SE |
| K223470 | C50NBL · Traditional | Sopro | 12/14/2023SE |
| K221249 | L1P-1F (Trios 5)NBL · Traditional | 3Shape TRIOS A/S | 09/16/2022SE |
| K183471 | IC-WHCD100 (Inspire)NBL · Traditional | Good Doctors Co., Ltd. | 07/02/2020SE |
| K171007 | Fluorescence ModeNBL · Traditional | Carl Zeiss Suzhou Co., Ltd. | 05/03/2018SE |
| K170822 | Electronic Caries DetectorNBL · Traditional | Ortek Therapeutics, Inc. | 09/11/2017SE |
| K150672 | VistaCam iX ProofNBL · Traditional | Durr Dental AG | 01/27/2016SE |
| K121685 | SoprocareNBL · Traditional | Sopro | 03/12/2013SE |
| K112139 | The Canary SystemNBL · Traditional | Quantum Dental Technologies, Inc. | 10/26/2012SE |
| K111423 | CS 1600 Intraoral CameraNBL · Traditional | Carestream Health, Inc. | 03/02/2012SE |
| K111321 | Remote View SoftwareNBL · Special | Cariescan , Ltd. | 05/17/2011SE |
| K093705 | FuorecamNBL · Traditional | Therapeutic Technologies, Inc. | 04/23/2010SE |
| K092583 | SoprolifeNBL · Traditional | Sopro | 01/13/2010SE |
| K090598 | Cariescan ProNBL · Traditional | Cariescan , Ltd. | 12/15/2009SE |
| K090169 | Spectra Fluorescence Caries Detection DeviceNBL · Traditional | Air Techniques, Inc. | 08/18/2009SE |
| K063321 | D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138NBL · Traditional | Neks Technologies, Inc. | 03/30/2007SE |
| K051909 | DiagnodentNBL · Traditional | Kavo America | 10/21/2005SE |
| K042394 | Diagnodent Perio Tip (Accessory)NBL · Traditional | Kavo America Corporation | 08/02/2005SE |
| K043156 | D-Carie, Model N121-M1NBL · Traditional | Neks Technologies, Inc. | 04/28/2005SE |
| K040063 | Inspektor ProNBL · Traditional | Inspektor Dental Care BV | 06/24/2004SE |