Cleared Abbreviated

StoneBite and StoneBite scan

K190571 · Dreve Dentamid GmbH · Dental
Nov 2019
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K190571 is an FDA 510(k) clearance for the StoneBite and StoneBite scan, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Dreve Dentamid GmbH (Unna, DE). The FDA issued a Cleared decision on November 7, 2019, 246 days after receiving the submission on March 6, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K190571 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2019
Decision Date November 07, 2019
Days to Decision 246 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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