Cleared Traditional

K203824 - VPS Impression Material

K203824 is an FDA 510(k) clearance for VPS Impression Material, manufactured by Hygedent, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K203824 · Hygedent, Inc. · Dental device
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Apr 2021
Decision
111d
Days
Class 2
Risk

K203824 is an FDA 510(k) clearance for the VPS Impression Material. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Hygedent, Inc. (Beijing, CN). The FDA issued a Cleared decision on April 19, 2021 after a review of 111 days - within the typical 510(k) review window.

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 Hygedent, Inc. devices

FDA 510(k) Submission Details - K203824

510(k) Number K203824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2020
Decision Date April 19, 2021
Days to Decision 111 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
16d faster than avg
Panel avg: 127d · This submission: 111d
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 199
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K203824.
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