Cleared Traditional

SYNERGY FLOW

K013400 · Coltene/Whaledent, Inc. · Dental
Dec 2001
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K013400 is an FDA 510(k) clearance for the SYNERGY FLOW, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Coltene/Whaledent, Inc. (Mahwah, US). The FDA issued a Cleared decision on December 10, 2001, 56 days after receiving the submission on October 15, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K013400 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2001
Decision Date December 10, 2001
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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