Cleared Traditional

K022150 - TRIONOMER

K022150 is an FDA 510(k) clearance for TRIONOMER, manufactured by Pentron Clinical Technologies. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K022150 · Pentron Clinical Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
50d
Days
Class 2
Risk

K022150 is an FDA 510(k) clearance for the TRIONOMER. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Pentron Clinical Technologies (Wallingford, US). The FDA issued a Cleared decision on August 21, 2002 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Pentron Clinical Technologies devices

FDA 510(k) Submission Details - K022150

510(k) Number K022150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2002
Decision Date August 21, 2002
Days to Decision 50 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
77d faster than avg
Panel avg: 127d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 389
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K022150.
AGC CEM
K030168 · Wieland Dental + Technik GmbH & Co. KG · Mar 2003
VITIQUE SYSTEM
K023649 · Dmg USA, Inc. · Jan 2003
TEMPORARY CEMENT-DC010002
K023727 · GC America, Inc. · Jan 2003
RELYX RMGIP
K022476 · 3M Company · Aug 2002
GC ELITE CEMENT 100
K021038 · GC America, Inc. · May 2002
PULPDENT POST CEMENT
K020481 · Pulpdent Corporation · Apr 2002