Cleared Traditional

K151262 - Hyflex Heavy

K151262 is the FDA 510(k) clearance for Hyflex Heavy by Osstem Implant Co., Ltd.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K151262 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
131d
Days
Class 2
Risk

K151262 is an FDA 510(k) clearance for the Hyflex Heavy, Hyflex Mono, Hyflex Light. 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 September 21, 2015 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 Osstem Implant Co., Ltd. devices

Submission Details

510(k) Number K151262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2015
Decision Date September 21, 2015
Days to Decision 131 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
4d slower than avg
Panel avg: 127d · This submission: 131d
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.
Patrick Lim

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 K151262.
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
Accu-Dent XD Tray, Accu-Dent XD Syringe
K143575 · Ivoclar Vivadent, Inc. · Apr 2015
GC BLUE SILICONE
K120521 · GC America, Inc. · May 2012
FIT CHECKER ADVANCED
K110871 · GC America, Inc. · Jun 2011