Cleared Traditional

PrimmaArt

K231859 · Dentscare Ltda · Dental
Nov 2024
Decision
522d
Days
Class 2
Risk

About This 510(k) Submission

K231859 is an FDA 510(k) clearance for the PrimmaArt, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Dentscare Ltda (Joinville, BR). The FDA issued a Cleared decision on November 26, 2024, 522 days after receiving the submission on June 23, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K231859 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2023
Decision Date November 26, 2024
Days to Decision 522 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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