Cleared Traditional

Well-Root PT

K252285 · Vericom Co., Ltd. · Dental
Sep 2025
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K252285 is an FDA 510(k) clearance for the Well-Root PT, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Vericom Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on September 19, 2025, 58 days after receiving the submission on July 23, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K252285 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2025
Decision Date September 19, 2025
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820