Cleared Traditional

DYNAFLEX

K103076 · Dyna Flex · Dental

Feb 2011

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K103076 is an FDA 510(k) clearance for the DYNAFLEX, a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by Dyna Flex (Austin, US). The FDA issued a Cleared decision on February 23, 2011, 128 days after receiving the submission on October 18, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number	K103076 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2010
Decision Date	February 23, 2011
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF