Cleared Traditional

HySil Plus Impression Materials

K210041 · Osstem Implant Co., Ltd. · Dental
Mar 2021
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K210041 is an FDA 510(k) clearance for the HySil Plus 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 March 18, 2021, 70 days after receiving the submission on January 7, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K210041 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2021
Decision Date March 18, 2021
Days to Decision 70 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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