Cleared Traditional

FLARE,FILE, FILL

K981234 · Lone Star Technologies · Dental
Jun 1998
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K981234 is an FDA 510(k) clearance for the FLARE,FILE, FILL, a Handle, Instrument, Dental (Class I — General Controls, product code EJB), submitted by Lone Star Technologies (Chatham, US). The FDA issued a Cleared decision on June 5, 1998, 62 days after receiving the submission on April 4, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K981234 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1998
Decision Date June 05, 1998
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJB — Handle, Instrument, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565