VioSeal Resin Root Canal Filling
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242702 FDA 510(k)
- FDA Product Code
- KIF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3820 FDA 510(k)
- Regulation Number
- 872.3820 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VioSeal Resin Root Canal Filling is a dental device classified as a resin-based material used for sealing root canals during endodontic treatment. It is designed to provide a hermetic seal within the root canal system, preventing microbial leakage and promoting long-term restoration stability.
This device is supplied as a single-use, sterile product and is intended for use in dental clinics and endodontic practices. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), adhering to Class II classification (FDA device class 2). The VioSeal is available in various registration numbers and product codes as listed in the regulatory submissions, ensuring compliance with dental specialty standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242702 | Class II | Active |
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Manufacturer
- Manufacturer
- Spident Co., Ltd.
Sources (2)
- FDA 510(k) K242702 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 19, 2026