Cleared Traditional

FIRST FILL R.C.S.

K011748 · Jeneric/Pentron, Inc. · Dental
Aug 2001
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K011748 is an FDA 510(k) clearance for the FIRST FILL R.C.S., a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on August 3, 2001, 58 days after receiving the submission on June 6, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K011748 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2001
Decision Date August 03, 2001
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