Cleared Traditional

DentMix VPS Impression Material

K223892 · Innovative Product Brands, Inc. · Dental
Apr 2023
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K223892 is an FDA 510(k) clearance for the DentMix VPS Impression Material, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Innovative Product Brands, Inc. (Highland, US). The FDA issued a Cleared decision on April 27, 2023, 120 days after receiving the submission on December 28, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K223892 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2022
Decision Date April 27, 2023
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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