Cleared Special

ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019

K062886 · CAO Group, Inc. · Dental
Nov 2006
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K062886 is an FDA 510(k) clearance for the ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by CAO Group, Inc. (West Jordan, US). The FDA issued a Cleared decision on November 6, 2006, 41 days after receiving the submission on September 26, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K062886 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2006
Decision Date November 06, 2006
Days to Decision 41 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBC — Sealant, Pit And Fissure, And Conditioner
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3765

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