White Endoseal MTA— 510(k) K212229

Substantially Equivalent

Maruchi

FDA 510(k) clearance K212229 for White Endoseal MTA, Substantially Equivalent on 2021-08-13. Applicant: Maruchi. Device class: 2.

Clearance details

Applicant: Maruchi
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2021-07-16
Decision date: 2021-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Wonju-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

K262050 — Vioseal X2026-09-11
K253909 — NeoPEX Pre-Mixed Obturation Paste2026-09-04
K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal)2026-08-25
K261415 — Injectable Root Canal Sealer (KP-Root SP)2026-06-29
K253167 — Any-Paste2026-01-12

More clearances from Maruchi

K213757 — Endocem MTA Premixed Regular2023-02-14
K202015 — White ENDOSEAL MTA2021-03-24
K201799 — CleaniCal2021-02-12
K170175 — ENDOSEAL MTA2018-02-26
K133042 — ENDOCEM ZR2014-05-12

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