Cleared Traditional

K183471 - IC-WHCD100 (Inspire) (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183471 · Good Doctors Co., Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Jul 2020
Decision
566d
Days
Class 2
Risk

K183471 is an FDA 510(k) clearance for the IC-WHCD100 (Inspire). Classified as Laser, Fluorescence Caries Detection (product code NBL), Class II - Special Controls.

Submitted by Good Doctors Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on July 2, 2020 after a review of 566 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1745 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Good Doctors Co., Ltd. devices

Submission Details

510(k) Number K183471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
439d slower than avg
Panel avg: 127d · This submission: 566d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBL Laser, Fluorescence Caries Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1745
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NBL Laser, Fluorescence Caries Detection

All 23
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