Cleared Traditional

HAPI Seal

K162598 · Bisco, Inc. · Dental
May 2017
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K162598 is an FDA 510(k) clearance for the HAPI Seal, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on May 23, 2017, 246 days after receiving the submission on September 19, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K162598 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2016
Decision Date May 23, 2017
Days to Decision 246 days
Submission Type Traditional
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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