Cleared Traditional

HySil Super Fast Impression Materials

K192941 · Osstem Implant Co., Ltd. · Dental
Jan 2020
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K192941 is an FDA 510(k) clearance for the HySil Super Fast 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 January 30, 2020, 104 days after receiving the submission on October 18, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K192941 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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