Cleared Traditional

Fixtemp C&B

K171729 · Dreve Dentamid GmbH · Dental
Dec 2017
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K171729 is an FDA 510(k) clearance for the Fixtemp C&B, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Dreve Dentamid GmbH (Unna, DE). The FDA issued a Cleared decision on December 13, 2017, 184 days after receiving the submission on June 12, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K171729 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2017
Decision Date December 13, 2017
Days to Decision 184 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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