Cleared Traditional

No Stress Impress

K213175 · No Stress Impress, LLC · Dental
Jan 2023
Decision
478d
Days
Class 2
Risk

About This 510(k) Submission

K213175 is an FDA 510(k) clearance for the No Stress Impress, a Material, Impression (Class II — Special Controls, product code ELW), submitted by No Stress Impress, LLC (Wilmington, US). The FDA issued a Cleared decision on January 19, 2023, 478 days after receiving the submission on September 28, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K213175 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2021
Decision Date January 19, 2023
Days to Decision 478 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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