CleaniCal

Liner, Cavity, Calcium Hydroxide

Maruchi

The following data is part of a premarket notification filed by Maruchi with the FDA for Cleanical.

Pre-market Notification Details

• Device ID: K201799
• 510k Number: K201799
• Device Name: CleaniCal
• Classification: Liner, Cavity, Calcium Hydroxide
• Applicant: Maruchi 2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan Wonju-si, KR 26311
• Contact: Jang Sung Wook
• Correspondent: Jang Sung Wook; Maruchi 2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan Wonju-si, KR 26311
• Product Code: EJK
• CFR Regulation Number: 872.3250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-06-30
• Decision Date: 2021-02-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800071200017	K201799	000