Cleared Traditional

ORL-E-92 SURGICAL DRILL SYSTEM (K984244) - FDA 510(k) Clearance

Class I Dental device.

K984244 · Bien Air USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
88d
Days
Class 1
Risk

K984244 is an FDA 510(k) clearance for the ORL-E-92 SURGICAL DRILL SYSTEM. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Bien Air USA, Inc. (San Diego, US). The FDA issued a Cleared decision on February 23, 1999 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Bien Air USA, Inc. devices

Submission Details

510(k) Number K984244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1998
Decision Date February 23, 1999
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EFB Handpiece, Air-powered, Dental

All 37
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K984244.
ESTYLUS ELECTRIC MOTOR SYSTEM
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K012720 · Dentsply Intl. · Nov 2001
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K003518 · Dentsply Intl. · Jan 2001
DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
K900093 · Dentsply Intl. · Apr 1990
DISPOSABLE PROPHY ANGLE AND ACCESSORIES
K897101 · Dentsply Intl. · Mar 1990
PLAQUE-SWEEP
K873209 · Dentsply Intl. · Aug 1987