Cleared Traditional

RETENTION FLOW OPAQUE

K062515 · Heraeus Kulzer,GmbH · Dental
Nov 2006
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K062515 is an FDA 510(k) clearance for the RETENTION FLOW OPAQUE, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Heraeus Kulzer,GmbH (South Bend, US). The FDA issued a Cleared decision on November 22, 2006, 86 days after receiving the submission on August 28, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K062515 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2006
Decision Date November 22, 2006
Days to Decision 86 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