Cleared Abbreviated

SA FLOWABLE ADHESIVE

K102603 · Dmg USA, Inc. · Dental
Nov 2010
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K102603 is an FDA 510(k) clearance for the SA FLOWABLE ADHESIVE, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on November 17, 2010, 68 days after receiving the submission on September 10, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K102603 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2010
Decision Date November 17, 2010
Days to Decision 68 days
Submission Type Abbreviated
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