Cleared Abbreviated

STATIS DENTAL HANDPIECES (K071891) - FDA 510(k) Clearance

Class I Dental device.

K071891 · Scican , Ltd. · Dental device
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Sep 2007
Decision
66d
Days
Class 1
Risk

K071891 is an FDA 510(k) clearance for the STATIS DENTAL HANDPIECES. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Scican , Ltd. (Toronto, CA). The FDA issued a Cleared decision on September 13, 2007 after a review of 66 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.

View all Scican , Ltd. devices

Submission Details

510(k) Number K071891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2007
Decision Date September 13, 2007
Days to Decision 66 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 127d · This submission: 66d
Pathway characteristics
Standards-based clearance path.

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 K071891.
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DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125
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ESTYLUS ELECTRIC MOTOR SYSTEM
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TULSA CONTRA ANGLES
K012720 · Dentsply Intl. · Nov 2001