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VioSeal Resin Root Canal Filling

by Spident Co., Ltd.

510(k) K242702

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242702↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK242702 Date7 Nov 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242702 decided 7 Nov 2024 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
VioSeal
510(k) Number
FDA product code
KIF
Device class
Class II
Regulation
21 CFR Part 872.3820
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code KIF (Resin, Root Canal Filling).

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