Cleared Traditional

K191034 - VPS Impression Material

K191034 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 139-day FDA review.

K191034 · Hygedent, Inc. · Dental device
Download Printable Device Report (PDF)
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Sep 2019
Decision
139d
Days
Class 2
Risk

K191034 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 September 4, 2019 after a review of 139 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 - K191034

510(k) Number K191034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2019
Decision Date September 04, 2019
Days to Decision 139 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
12d slower than avg
Panel avg: 127d · This submission: 139d
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 K191034.
Lascod Impression Materials
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Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
K181604 · Hrs Co., Ltd. · Nov 2018
HySil Impression Materials
K181236 · Osstem Implant Co., Ltd. · Sep 2018
AIM2
K181011 · GC America, Inc. · Jul 2018