Cleared Traditional

SPEE-DEE PATCH

K113617 · Pulpdent Corporation · Dental
Mar 2012
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K113617 is an FDA 510(k) clearance for the SPEE-DEE PATCH, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on March 2, 2012, 86 days after receiving the submission on December 7, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K113617 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2011
Decision Date March 02, 2012
Days to Decision 86 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