Cleared Traditional

K981234 - FLARE,FILE, FILL

K981234 is an FDA 510(k) clearance for FLARE, manufactured by Lone Star Technologies. The device is a Class 1 Dental device with product code EJB cleared through the Traditional 510(k) pathway after a 62-day FDA review.

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.

FDA 510(k) Submission Details - K981234

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 128d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

EJB Device Classification - Class 1, General Controls

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.

Regulatory Peers - EJB Handle, Instrument, Dental

All 7
Devices cleared under the same product code (EJB) and FDA review panel - the closest regulatory comparables to K981234.
BENDA WEDGE
K140144 · Centrix, Inc. · Jul 2014
DETECTAR, MODEL N123-MI
K023367 · Neks Technologies · Jun 2003
AUKUSLEEVE
K930094 · Aukland Medical Plastics, Inc. · Oct 1993
CAVI-ZYME
K922633 · E&D Dental Products, Inc. · Aug 1992
SPATULA, DENTAL, CEMENT
K871818 · Military Engineering, Inc. · Jul 1987
TOOTH SLOOTH
K833338 · Joel Lander D.D.S. · Nov 1983
K981234 · FLARE,FILE, FILL
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