Cleared Traditional

Vista BC Putty

K241457 · Inter-Med, Inc. · Dental
Aug 2024
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K241457 is an FDA 510(k) clearance for the Vista BC Putty, 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 August 28, 2024, 97 days after receiving the submission on May 23, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K241457 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2024
Decision Date August 28, 2024
Days to Decision 97 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