Cleared Traditional

K193496 - CharmFil

K193496 is the FDA 510(k) clearance for CharmFil by Dentkist, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K193496 · Dentkist, Inc. · Dental device
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May 2020
Decision
141d
Days
Class 2
Risk

K193496 is an FDA 510(k) clearance for the CharmFil. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentkist, Inc. (Gunpo-Si, KR). The FDA issued a Cleared decision on May 6, 2020 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentkist, Inc. devices

Submission Details

510(k) Number K193496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2019
Decision Date May 06, 2020
Days to Decision 141 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 127d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 Consultant

Plusglobal
Peter Chung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 516
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