Cleared Traditional

Vista BC Sealer

K221811 · Inter-Med, Inc. · Dental
Nov 2022
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K221811 is an FDA 510(k) clearance for the Vista BC Sealer, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on November 21, 2022, 152 days after receiving the submission on June 22, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K221811 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2022
Decision Date November 21, 2022
Days to Decision 152 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