Cleared Abbreviated

FotoDent denture

K200580 · Dreve Dentamid GmbH · Dental
Nov 2020
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K200580 is an FDA 510(k) clearance for the FotoDent denture, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Dreve Dentamid GmbH (Unna, DE). The FDA issued a Cleared decision on November 19, 2020, 259 days after receiving the submission on March 5, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K200580 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2020
Decision Date November 19, 2020
Days to Decision 259 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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