Cleared Traditional

BioHPP - breCAM.BioHPP

K152113 · Bredent GmbH & Co. KG · Dental
Jul 2016
Decision
358d
Days
Class 2
Risk

About This 510(k) Submission

K152113 is an FDA 510(k) clearance for the BioHPP - breCAM.BioHPP, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Bredent GmbH & Co. KG (Senden, DE). The FDA issued a Cleared decision on July 21, 2016, 358 days after receiving the submission on July 29, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K152113 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2015
Decision Date July 21, 2016
Days to Decision 358 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