Cleared Traditional

CleaniCal

K201799 · Maruchi · Dental
Feb 2021
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K201799 is an FDA 510(k) clearance for the CleaniCal, a Liner, Cavity, Calcium Hydroxide (Class II — Special Controls, product code EJK), submitted by Maruchi (Wonju-Si, KR). The FDA issued a Cleared decision on February 12, 2021, 227 days after receiving the submission on June 30, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K201799 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2020
Decision Date February 12, 2021
Days to Decision 227 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJK — Liner, Cavity, Calcium Hydroxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3250

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