C50
FDA 510(k) K223470 · Sopro
510(k) numberK223470
Submission
- Device name
- C50
- Applicant
- Sopro
La Ciotat, FR - Received
- November 17, 2022
- Decision date
- December 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NBL
| 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 |
| 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 |
More from Sopro
| 510(k) | Device | Decision |
|---|---|---|
| K121685 | SoprocareNBL · Traditional | 03/12/2013SE |
| K103813 | Sopro 281NTN · Traditional | 03/22/2011SE |
| K092329 | Sopix 2MUH · Traditional | 07/20/2010SE |
| K092583 | SoprolifeNBL · Traditional | 01/13/2010SE |
| K082796 | Sopro 184 CameraGCJ · Traditional | 04/01/2009SE |
| K080122 | Sopro 670 Arthroscopic PumpHRX · Traditional | 07/11/2008SE |
| K070783 | Sopro Model 640 Laparoscopic InsufflatorHIF · Traditional | 12/13/2007SE |
| K072912 | Sopro 225 Dual Halogen Light SourceGCJ · Traditional | 11/16/2007SE |
| K070102 | Sopro 162 CameraGCJ · Traditional | 02/20/2007SE |
| K031593 | Sopro 61DGCJ · Traditional | 09/16/2003SE |
Questions and answers
When was C50 cleared by the FDA?
C50 (K223470) received a 510(k) decision of Substantially Equivalent on December 14, 2023, 392 days after the submission was received.
What is the product code of K223470?
The FDA product code is NBL – Light-Induced Fluorescence Caries Detector , a Class II (moderate risk) device regulated under 21 CFR 872.1745.