Cleared Traditional

K170812 - HygePLUS Alginate Impression Material

K170812 is an FDA 510(k) clearance for HygePLUS Alginate 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 131-day FDA review.

K170812 · Hygedent, Inc. · Dental device
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Jul 2017
Decision
131d
Days
Class 2
Risk

K170812 is an FDA 510(k) clearance for the HygePLUS Alginate 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 July 26, 2017 after a review of 131 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 - K170812

510(k) Number K170812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2017
Decision Date July 26, 2017
Days to Decision 131 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
4d slower than avg
Panel avg: 127d · This submission: 131d
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 200
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K170812.
AIM2
K181011 · GC America, Inc. · Jul 2018
PEAK NS033CF, PEAK NS017CF
K180565 · Neosil Co., Ltd. · Jun 2018
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
K171562 · Dreve Dentamid GmbH · Apr 2018
HySil Impression Materials
K170736 · Osstem Implant Co., Ltd. · Jun 2017
Identic and KromaFaze Alginate Dental Impression Materials
K160441 · Kerr Corporation · Jun 2016
NoCord
K152826 · Centrix, Inc. · May 2016