510(k) K183471
K183471 is an FDA 510(k) premarket notification submitted by Good Doctors Co., Ltd. for the device "IC-WHCD100 (Inspire)". The FDA issued a decision of Substantially Equivalent on July 2, 2020. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745. Good Doctors Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2020
- Date Received
- December 14, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light-Induced Fluorescence Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type