Vioseal X— 510(k) K262050
Substantially EquivalentSpident 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 a root canal sealer, filed under KIF, resin root canal filling materials. Sealers fill the gaps between the gutta-percha core and the canal walls after the canal has been cleaned and shaped.
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). Endodontic materials are a mature category, and a clock under 90 days is normal here.
Clearance details
- Applicant
- Spident Co., Ltd.
- Product code
- Code KIF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3820
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Incheon, KR
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