Cleared Traditional

K093084 - ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP

K093084 is an FDA 510(k) clearance for ROLENCE DENTAL HIGH SPEED HANDPIECE, manufactured by Rolence Ent., Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K093084 · Rolence Ent., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
76d
Days
Class 1
Risk

K093084 is an FDA 510(k) clearance for the ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Rolence Ent., Inc. (Hsin Chu City, TW). The FDA issued a Cleared decision on December 16, 2009 after a review of 76 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 Rolence Ent., Inc. devices

FDA 510(k) Submission Details - K093084

510(k) Number K093084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2009
Decision Date December 16, 2009
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
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 110
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K093084.
AIR-N-GO
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EMS AIR-FLOW HANDY PERIO
K092289 · E.M.S Electro Medical Systems S.A · Oct 2009
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065 · J. Morita USA, Inc. · Oct 2009
CONTRA-ANGLE HANDPIECE KOMET OS30
K090548 · W&H Dentalwerk Buermoos GmbH · Jun 2009