Cleared Traditional

K180682 - AeroPro Cordless Prophy System

K180682 is the FDA 510(k) clearance for AeroPro Cordless Prophy System by Premier Dental Company Products. It is a Class 1 Dental device (product code EKX) cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K180682 · Premier Dental Company Products · Dental device
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Feb 2019
Decision
349d
Days
Class 1
Risk

K180682 is an FDA 510(k) clearance for the AeroPro Cordless Prophy System. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Premier Dental Company Products (Plymouth Meeting, US). The FDA issued a Cleared decision on February 27, 2019 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Premier Dental Company Products devices

Submission Details

510(k) Number K180682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2018
Decision Date February 27, 2019
Days to Decision 349 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 127d · This submission: 349d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKX Handpiece, Direct Drive, Ac-powered
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 - EKX Handpiece, Direct Drive, Ac-powered

All 43
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