Cleared Traditional

VioSeal (K242702) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242702 · Spident Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
59d
Days
Class 2
Risk

K242702 is an FDA 510(k) clearance for the VioSeal. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Spident Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on November 7, 2024 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spident Co., Ltd. devices

Submission Details

510(k) Number K242702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2024
Decision Date November 07, 2024
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 127d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KIF Resin, Root Canal Filling

All 58
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K242702.
One-Fil Putty
K243353 · Mediclus Co., Ltd. · Mar 2025
AH Plus Endodontic Sealer
K243546 · Dentsply Sirona, Inc. · Feb 2025
Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
K242934 · Longly Biotechnology (Wuhan) Co., Ltd. · Dec 2024
Injectable Root Canal Bioceramic Sealer (i-MTA SP)
K241977 · Longly Biotechnology (Wuhan) Co., Ltd. · Oct 2024
Vista BC Putty
K241457 · Inter-Med, Inc. · Aug 2024
Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
K240446 · Shiva Products · Jul 2024