510(k) clearance
Vioseal X
- 510(k) number
- K262050
- Applicant
- Spident Co., Ltd.
- Decision date
- Sep 11, 2026
- Date received
- Jun 18, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KIF
- Device type
- Resin, Root Canal Filling
- Device class
- Class II
- Regulation
- 21 CFR 872.3820
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Incheon, KR