Cleared Traditional

Ecosite Bulk Fill

K171772 · Dmg USA, Inc. · Dental
Jan 2018
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K171772 is an FDA 510(k) clearance for the Ecosite Bulk Fill, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Dmg USA, Inc. (Attleboro, US). The FDA issued a Cleared decision on January 31, 2018, 231 days after receiving the submission on June 14, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K171772 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2017
Decision Date January 31, 2018
Days to Decision 231 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690