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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 128d · 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 Consultant

Globizz Corporation
Takahiro Haruyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBG Crown And Bridge, Temporary, Resin

All 172
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K172281.
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
Fixtemp C&B
K171729 · Dreve Dentamid GmbH · Dec 2017
DD medical polymers
K153490 · Dental Direkt GmbH · May 2016
Vericore Gradient Temporary Disc
K152443 · Whip Mix Corporation · May 2016
TelioCAD Multi
K153753 · Ivoclar Vivadent, Inc. · Apr 2016