Cleared Traditional

FLARE,FILE, FILL (K981234) - FDA 510(k) Clearance

Class I Dental device.

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

K981234 is an FDA 510(k) clearance for the FLARE,FILE, FILL. Classified as Handle, Instrument, Dental (product code EJB), Class I - General Controls.

Submitted by Lone Star Technologies (Chatham, US). The FDA issued a Cleared decision on June 5, 1998 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Lone Star Technologies devices

Submission Details

510(k) Number K981234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 127d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJB Handle, Instrument, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.