IC-WHCD100 (Inspire)
FDA 510(k) K183471 · Good Doctors Co., Ltd.
510(k) numberK183471
Submission
- Device name
- IC-WHCD100 (Inspire)
- Applicant
- Good Doctors Co., Ltd.
Incheon, KR - Received
- December 14, 2018
- Decision date
- July 2, 2020
- 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 |
| K223470 | C50NBL · Traditional | Sopro | 12/14/2023SE |
| K221249 | L1P-1F (Trios 5)NBL · Traditional | 3Shape TRIOS A/S | 09/16/2022SE |
| 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 |
|---|---|---|
| K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE)EBZ · Traditional | 08/04/2023SE |
| K173157 | Dr's Light2EBZ · Traditional | 05/29/2018SE |
| K171867 | Drs Finder NEOLQY · Traditional | 03/30/2018SE |
| K151274 | Dr's FinderLQY · Traditional | 02/04/2016SE |
| K093751 | CL-DC20, CL-DC21EBZ · Traditional | 02/24/2010SE |
| K071908 | Doctor's Light LED Dental Curing LightEBZ · Traditional | 08/23/2007SE |
Questions and answers
When was IC-WHCD100 (Inspire) cleared by the FDA?
IC-WHCD100 (Inspire) (K183471) received a 510(k) decision of Substantially Equivalent on July 2, 2020, 566 days after the submission was received.
What is the product code of K183471?
The FDA product code is NBL – Light-Induced Fluorescence Caries Detector , a Class II (moderate risk) device regulated under 21 CFR 872.1745.