EsFlow PLUS— 510(k) K250317

Substantially Equivalent

Spident Co., Ltd.

FDA 510(k) clearance K250317 for EsFlow PLUS, Substantially Equivalent on 2025-05-30. Applicant: Spident Co., Ltd.. Device class: 2.

Clearance details

Applicant: Spident Co., Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2025-02-04
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

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K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Spident Co., Ltd.

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K242702 — VioSeal2024-11-07
K242675 — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)2024-11-01

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