Cleared Traditional

DOC'S BEST WHITE COPPER CEMENT (K031494) - FDA 510(k) Clearance

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

K031494 · Cooley & Cooley, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
183d
Days
Class 2
Risk

K031494 is an FDA 510(k) clearance for the DOC'S BEST WHITE COPPER CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Cooley & Cooley, Ltd. (Houston, US). The FDA issued a Cleared decision on November 12, 2003 after a review of 183 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Cooley & Cooley, Ltd. devices

Submission Details

510(k) Number K031494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2003
Decision Date November 12, 2003
Days to Decision 183 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
56d slower than avg
Panel avg: 127d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 80
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K031494.
DYRACT CEM PLUS CEMENT
K041272 · Dentsply Intl. · Oct 2004
CALIBRA CEMENT
K040906 · Dentsply Intl. · Jun 2004
INTEGRITY TEMPORARY CEMENT
K040895 · Dentsply Intl. · May 2004
RELYX RMGIP
K022476 · 3M Company · Aug 2002
GILB, MODEL 8010
K011200 · 3M Company · Jun 2001
DYRACT CEM LCI COMPOMER
K003921 · Dentsply Intl. · Jan 2001