Cleared Traditional

ORALUBE (K000847) - FDA 510(k) Clearance

Class I Dental device.

K000847 · Orasystems · Dental device
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Sep 2000
Decision
196d
Days
Class 1
Risk

K000847 is an FDA 510(k) clearance for the ORALUBE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Orasystems (Morris Plains, US). The FDA issued a Cleared decision on September 27, 2000 after a review of 196 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Orasystems devices

Submission Details

510(k) Number K000847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2000
Decision Date September 27, 2000
Days to Decision 196 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
69d slower than avg
Panel avg: 127d · This submission: 196d
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 K000847.
ESTYLUS ELECTRIC MOTOR SYSTEM
K031145 · Dentsply Intl. · Jul 2003
TULSA CONTRA ANGLES
K012720 · Dentsply Intl. · Nov 2001
RAPIDD HIGHSPEED DENTAL HANDPIECE
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