Cleared Traditional

K152766 - CharmFlex

K152766 is an FDA 510(k) clearance for CharmFlex, manufactured by Dentkist, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K152766 · Dentkist, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
166d
Days
Class 2
Risk

K152766 is an FDA 510(k) clearance for the CharmFlex. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dentkist, Inc. (Gunpo-Si, KR). The FDA issued a Cleared decision on March 8, 2016 after a review of 166 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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

FDA 510(k) Submission Details - K152766

510(k) Number K152766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2015
Decision Date March 08, 2016
Days to Decision 166 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
39d slower than avg
Panel avg: 127d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 238
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K152766.
i-Sil
K161774 · Spident Co., Ltd. · Sep 2016
Identic and KromaFaze Alginate Dental Impression Materials
K160441 · Kerr Corporation · Jun 2016
NoCord
K152826 · Centrix, Inc. · May 2016
Vonflex S Putty
K152518 · Vericom Co., Ltd. · Nov 2015
Cavex Cream Alginate
K151535 · Cavex Holland BV · Oct 2015
Hyflex Heavy, Hyflex Mono, Hyflex Light
K151262 · Osstem Implant Co., Ltd. · Sep 2015