Cleared Traditional

PuRE PMMA Disc (K172281) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 63
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K172281.
Harvest Dental Polymer Blocks
K180578 · Harvest Dental Products, LLC · Dec 2018
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
MSN-006
K141562 · GC America, Inc. · Sep 2014
STRUCTUR 3
K120779 · Voco GmbH · Jun 2012
TEMPORARY C&B COMPOSITE
K091894 · Voco GmbH · Jul 2009