EsCem RMGI— 510(k) K250566

Substantially Equivalent

Spident Co., Ltd.

FDA 510(k) clearance K250566 for EsCem RMGI, Substantially Equivalent on 2025-06-20. Applicant: Spident Co., Ltd.. Device class: 2.

Clearance details

Applicant: Spident Co., Ltd.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2025-02-26
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Spident Co., Ltd.

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