Cleared Traditional

Resin for Temporary Crown & Bridge

K180657 · Dentis Co., Ltd. · Dental
Dec 2018
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K180657 is an FDA 510(k) clearance for the Resin for Temporary Crown & Bridge, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on December 7, 2018, 269 days after receiving the submission on March 13, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K180657 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2018
Decision Date December 07, 2018
Days to Decision 269 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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