Cleared Abbreviated

Elastic Impression Material

K241924 · Beijing Okvd Biological Technology , Ltd. · Dental
Dec 2024
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K241924 is an FDA 510(k) clearance for the Elastic Impression Material, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Beijing Okvd Biological Technology , Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 27, 2024, 179 days after receiving the submission on July 1, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K241924 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2024
Decision Date December 27, 2024
Days to Decision 179 days
Submission Type Abbreviated
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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