Cleared Abbreviated

K072554 - ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES

K072554 is an FDA 510(k) clearance for ACCESS AND ROTAMAX FIBER OPTIC HIGH SPE..., manufactured by Sable Industries, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Abbreviated 510(k) pathway after a 65-day FDA review.

K072554 · Sable Industries, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
65d
Days
Class 1
Risk

K072554 is an FDA 510(k) clearance for the ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Sable Industries, Inc. (Erie, US). The FDA issued a Cleared decision on November 14, 2007 after a review of 65 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K072554

510(k) Number K072554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2007
Decision Date November 14, 2007
Days to Decision 65 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 128d · This submission: 65d
Pathway characteristics
Standards-based clearance path.

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 240
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K072554.
AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE
K072754 · Axenic Dental, Inc. · Jan 2008
AIR-FLOW MASTER STANDARD
K073284 · (Ems Sa) Electro Medical Systems · Dec 2007
DO-ALL DENTAL HANDPIECE LUBRICANT
K073353 · Prodrive Systems, Inc. · Dec 2007
HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D
K071561 · Beijing North Pole Dental Handpiece Co., Ltd. · Oct 2007
STATIS DENTAL HANDPIECES
K071891 · Scican , Ltd. · Sep 2007
I-SURGE
K071965 · Satelec · Sep 2007
K072554 · ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES
Download PDF FDA Summary Sable Industries, Inc.