Cleared Traditional

K172281 - PuRE PMMA Disc

K172281 is an FDA 510(k) clearance for PuRE PMMA Disc, manufactured by Quest Dental USA Corp.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K172281 · Quest Dental USA Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
83d
Days
Class 2
Risk

K172281 is an FDA 510(k) clearance for the PuRE PMMA Disc. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Quest Dental USA Corp. (Irvine, US). The FDA issued a Cleared decision on October 19, 2017 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Quest Dental USA Corp. devices

FDA 510(k) Submission Details - K172281

510(k) Number K172281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2017
Decision Date October 19, 2017
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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.

Regulatory Peers - EBG Crown And Bridge, Temporary, Resin

All 113
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K172281.
Harvest Dental Polymer Blocks
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Resin for Temporary Crown & Bridge
K180657 · Dentis Co., Ltd. · Dec 2018
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
K180562 · Zirkonzahn GmbH · Jun 2018
TelioCAD Multi
K153753 · Ivoclar Vivadent, Inc. · Apr 2016
MSN-006
K141562 · GC America, Inc. · Sep 2014
TUFF-TEMP 2.0
K120784 · Pulpdent Corporation · Jun 2012