Cleared Traditional

WELL-PASTE

K090992 · Vericom Co., Ltd. · Dental
Apr 2009
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K090992 is an FDA 510(k) clearance for the WELL-PASTE, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Vericom Co., Ltd. (Tustin, US). The FDA issued a Cleared decision on April 21, 2009, 14 days after receiving the submission on April 7, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K090992 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2009
Decision Date April 21, 2009
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820