Cleared Traditional

IC-WHCD100 (Inspire)

K183471 · Good Doctors Co., Ltd. · Dental
Jul 2020
Decision
566d
Days
Class 2
Risk

About This 510(k) Submission

K183471 is an FDA 510(k) clearance for the IC-WHCD100 (Inspire), a Laser, Fluorescence Caries Detection (Class II — Special Controls, product code NBL), submitted by Good Doctors Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on July 2, 2020, 566 days after receiving the submission on December 14, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K183471 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2018
Decision Date July 02, 2020
Days to Decision 566 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NBL — Laser, Fluorescence Caries Detection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1745