Cleared Traditional

TUFF-TEMP 2.0

K120784 · Pulpdent Corporation · Dental
Jun 2012
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K120784 is an FDA 510(k) clearance for the TUFF-TEMP 2.0, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on June 8, 2012, 85 days after receiving the submission on March 15, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K120784 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2012
Decision Date June 08, 2012
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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