Cleared Abbreviated

K170261 - Premium Plus Prophy Air Motor

K170261 is an FDA 510(k) clearance for Premium Plus Prophy Air Motor, manufactured by Premium Plus International Limited. The device is a Class 1 Dental device with product code EFB cleared through the Abbreviated 510(k) pathway after a 265-day FDA review.

K170261 · Premium Plus International Limited · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
265d
Days
Class 1
Risk

K170261 is an FDA 510(k) clearance for the Premium Plus Prophy Air Motor. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Premium Plus International Limited (Hong Kong, CN). The FDA issued a Cleared decision on October 19, 2017 after a review of 265 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 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 Premium Plus International Limited devices

FDA 510(k) Submission Details - K170261

510(k) Number K170261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2017
Decision Date October 19, 2017
Days to Decision 265 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 127d · This submission: 265d
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 95
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K170261.
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