Cleared Abbreviated

K163228 - APVolution System

K163228 is an FDA 510(k) clearance for APVolution System, manufactured by Aesthetic-Press, LLC. The device is a Class 2 Dental device with product code EIH cleared through the Abbreviated 510(k) pathway after a 200-day FDA review.

K163228 · Aesthetic-Press, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
200d
Days
Class 2
Risk

K163228 is an FDA 510(k) clearance for the APVolution System. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Aesthetic-Press, LLC (New Port Richey, US). The FDA issued a Cleared decision on June 5, 2017 after a review of 200 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Aesthetic-Press, LLC devices

FDA 510(k) Submission Details - K163228

510(k) Number K163228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2016
Decision Date June 05, 2017
Days to Decision 200 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
73d slower than avg
Panel avg: 127d · This submission: 200d
Pathway characteristics
Standards-based clearance path.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

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