Cleared Traditional

Well-Root ST

K170950 · Vericom Co., Ltd. · Dental
Dec 2017
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K170950 is an FDA 510(k) clearance for the Well-Root ST, 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 December 20, 2017, 264 days after receiving the submission on March 31, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K170950 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2017
Decision Date December 20, 2017
Days to Decision 264 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