Cleared Traditional

K170736 - HySil Impression Materials

K170736 is the FDA 510(k) clearance for HySil 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 89-day FDA review.

K170736 · Osstem Implant Co., Ltd. · Dental device
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Jun 2017
Decision
89d
Days
Class 2
Risk

K170736 is an FDA 510(k) clearance for the HySil 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 June 7, 2017 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osstem Implant Co., Ltd. devices

Submission Details

510(k) Number K170736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2017
Decision Date June 07, 2017
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
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.
DAVID KIM

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 101
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K170736.
AIM2
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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
Hyflex Heavy, Hyflex Mono, Hyflex Light
K151262 · Osstem Implant Co., Ltd. · Sep 2015
Accu-Dent XD Tray, Accu-Dent XD Syringe
K143575 · Ivoclar Vivadent, Inc. · Apr 2015
GC BLUE SILICONE
K120521 · GC America, Inc. · May 2012