Cleared Traditional

K000847 - ORALUBE

K000847 is an FDA 510(k) clearance for ORALUBE, manufactured by Orasystems. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 196-day FDA review.

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.

FDA 510(k) Submission Details - K000847

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
68d slower than avg
Panel avg: 128d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

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 259
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K000847.
RAPIDD HIGHSPEED DENTAL HANDPIECE
K003518 · Dentsply Intl. · Jan 2001
CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO
K000834 · Castellini S.P.A. · Dec 2000
TDK HANDPIECES
K000848 · Orasystems · Oct 2000
MD 10, SEM, SM 12, CBM
K000710 · NOUVAG AG · May 2000
ATR TECNIKA
K000547 · Advanced Technology Research (A.T.R.) S.R.P. · May 2000
SUNI MAX
K000049 · Satelec · Apr 2000
K000847 · ORALUBE
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