Cleared Traditional

PULPDENT MICRO-HYBRID COMPOSITE

K090391 · Pulpdent Corporation · Dental
May 2009
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K090391 is an FDA 510(k) clearance for the PULPDENT MICRO-HYBRID COMPOSITE, 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 May 11, 2009, 83 days after receiving the submission on February 17, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K090391 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2009
Decision Date May 11, 2009
Days to Decision 83 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