Cleared Traditional

K112869 - EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400

K112869 is an FDA 510(k) clearance for EASYPROPHY SERIES AIR POLISH DEVICES, manufactured by Beyes Dental Canada, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K112869 · Beyes Dental Canada, Inc. · Dental device
Download Printable Device Report (PDF)
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Dec 2011
Decision
77d
Days
Class 1
Risk

K112869 is an FDA 510(k) clearance for the EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Beyes Dental Canada, Inc. (Dover, US). The FDA issued a Cleared decision on December 16, 2011 after a review of 77 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 Beyes Dental Canada, Inc. devices

FDA 510(k) Submission Details - K112869

510(k) Number K112869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date December 16, 2011
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 98
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