Cleared Traditional

Papacarie Duo

K233768 · Elevate Oral Care · Dental
Jul 2024
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K233768 is an FDA 510(k) clearance for the Papacarie Duo, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Elevate Oral Care (West Palm Beach, US). The FDA issued a Cleared decision on July 18, 2024, 237 days after receiving the submission on November 24, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K233768 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2023
Decision Date July 18, 2024
Days to Decision 237 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LBH — Varnish, Cavity
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260

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