Cleared Traditional

HySil Impression Materials

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

About This 510(k) Submission

K170736 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 June 7, 2017, 89 days after receiving the submission on March 10, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K170736 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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