Dia-Proseal— 510(k) K182009

Substantially Equivalent

DiaDent Group International

FDA 510(k) clearance K182009 for Dia-Proseal, Substantially Equivalent on 2019-09-26. 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: 2018-07-27
Decision date: 2019-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongji-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

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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 DiaDent Group International

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K261166 — DIA-CEM2026-07-09
K261093 — DIAFIL2026-06-02
K261071 — DIAFIL Bulk FLOW (3 models)2026-05-19

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