DIA-ROOT BIO Sealer— 510(k) K200175

Name: FDA 510(k) clearance K200175
Creator: U.S. Food and Drug Administration
Published: 2020-06-25

Substantially Equivalent

DiaDent Group International

FDA 510(k) clearance K200175 for DIA-ROOT BIO Sealer, Substantially Equivalent on 2020-06-25. Applicant: DiaDent Group International. Device class: 2.

Clearance details

Applicant: DiaDent Group International
Product code: Product code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2020-01-23
Decision date: 2020-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

Download summary PDF View on FDA.gov ↗

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K261415 — Injectable Root Canal Sealer (KP-Root SP)2026-06-29
K253167 — Any-Paste2026-01-12

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K261071 — DIAFIL Bulk FLOW (3 models)2026-05-19

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