Cleared Abbreviated

BA Pit & Fissure Sealant

K190998 · Apex Dental Materials, Inc. · Dental
Nov 2019
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K190998 is an FDA 510(k) clearance for the BA Pit & Fissure Sealant, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Apex Dental Materials, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on November 8, 2019, 206 days after receiving the submission on April 16, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K190998 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2019
Decision Date November 08, 2019
Days to Decision 206 days
Submission Type Abbreviated
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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