Cleared Traditional

K192941 - HySil Super Fast Impression Materials

K192941 is the FDA 510(k) clearance for HySil Super Fast Impression Materials by Osstem Implant Co., Ltd.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K192941 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
104d
Days
Class 2
Risk

K192941 is an FDA 510(k) clearance for the HySil Super Fast Impression Materials. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on January 30, 2020 after a review of 104 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 Osstem Implant Co., Ltd. devices

Submission Details

510(k) Number K192941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2019
Decision Date January 30, 2020
Days to Decision 104 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
23d faster than avg
Panel avg: 127d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Hiossen, Inc.
Peter Lee

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 - ELW Material, Impression

All 140
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K192941.
Impression Material
K201483 · Zhengzhou Huaer Electro Optics Technology Co., Ltd. · Oct 2020
A-Silicone for Bite Registration
K201684 · Shandong Huge Dental Material Corporation · Sep 2020
Lascod Impression Materials
K201184 · Lascod Spa · May 2020
StoneBite and StoneBite scan
K190571 · Dreve Dentamid GmbH · Nov 2019
VPS Impression Material
K191034 · Hygedent, Inc. · Sep 2019
Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
K181604 · Hrs Co., Ltd. · Nov 2018