Cleared Traditional

BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P

K101064 · Bredent GmbH & Co. KG · Dental

Sep 2010

Decision

151d

Days

Class 2

Risk

About This 510(k) Submission

K101064 is an FDA 510(k) clearance for the BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P, a Denture, Plastic, Teeth (Class II — Special Controls, product code ELM), submitted by Bredent GmbH & Co. KG (Tuttlingen, Baden Wurttemberg, DE). The FDA issued a Cleared decision on September 14, 2010, 151 days after receiving the submission on April 16, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3590.

Submission Details

510(k) Number	K101064 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 16, 2010
Decision Date	September 14, 2010
Days to Decision	151 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF