Vioseal X— 510(k) K262050

Substantially Equivalent

Spident Co., Ltd.

FDA 510(k) clearance K262050 for Vioseal X, Substantially Equivalent on 2026-09-11. Applicant: Spident Co., Ltd.. Device class: 2.

Summary

Vioseal X is filed under KIF, resin root canal filling materials. The record doesn't describe its composition.

Class II, 21 CFR 872.3820. The Dental panel reviewed it as a Traditional 510(k).

Spident filed from Incheon, South Korea. Review took 85 days (June 18 to September 11, 2026).

Clearance details

Applicant: Spident Co., Ltd.
Product code: Product code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2026-06-18
Decision date: 2026-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

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