Cleared Traditional

HySil Impression Materials

K181236 · Osstem Implant Co., Ltd. · Dental
Sep 2018
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K181236 is an FDA 510(k) clearance for the HySil Impression Materials, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on September 13, 2018, 126 days after receiving the submission on May 10, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K181236 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2018
Decision Date September 13, 2018
Days to Decision 126 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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