Cleared Traditional

PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL

K081810 · Pulpdent Corporation · Dental
Sep 2008
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K081810 is an FDA 510(k) clearance for the PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL, 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 September 17, 2008, 83 days after receiving the submission on June 26, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K081810 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2008
Decision Date September 17, 2008
Days to Decision 83 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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