Cleared Traditional

SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S

K132984 · Ivoclar Vivadent, Inc. · Dental

Jan 2014

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K132984 is an FDA 510(k) clearance for the SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S, a Denture, Plastic, Teeth (Class II — Special Controls, product code ELM), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on January 14, 2014, 112 days after receiving the submission on September 24, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3590.

Submission Details

510(k) Number	K132984 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2013
Decision Date	January 14, 2014
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF