Cleared Traditional

Parkell Self-Adhesive Cement

K210259 · Parkell, Inc. · Dental
Jan 2022
Decision
353d
Days
Class 2
Risk

About This 510(k) Submission

K210259 is an FDA 510(k) clearance for the Parkell Self-Adhesive Cement, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on January 20, 2022, 353 days after receiving the submission on February 1, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K210259 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2021
Decision Date January 20, 2022
Days to Decision 353 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275