CleaniCal— 510(k) K201799

Substantially Equivalent

Maruchi

FDA 510(k) clearance K201799 for CleaniCal, Substantially Equivalent on 2021-02-12. Applicant: Maruchi. Device class: 2.

Clearance details

Applicant: Maruchi
Product code: Code EJK
Device class: Class 2
Regulation: 21 CFR 872.3250
Advisory panel: Dental
Date received: 2020-06-30
Decision date: 2021-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJK

K261728 — One-Fil LC2026-07-21
K253248 — Bright Cavity Liner2026-01-13
K230270 — 3M VitCal Liner/Base2023-02-06
K212475 — Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)2022-05-13
K202413 — LC ResinCal PC2020-11-20

More clearances from Maruchi

K213757 — Endocem MTA Premixed Regular2023-02-14
K212229 — White Endoseal MTA2021-08-13
K202015 — White ENDOSEAL MTA2021-03-24
K170175 — ENDOSEAL MTA2018-02-26
K133042 — ENDOCEM ZR2014-05-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.