Cleared Traditional

K053040 - PARACEM UNIVERSAL DC

K053040 is the FDA 510(k) clearance for PARACEM UNIVERSAL DC by Coltene/Whaledent AG. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K053040 · Coltene/Whaledent AG · Dental device
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Nov 2005
Decision
13d
Days
Class 2
Risk

K053040 is an FDA 510(k) clearance for the PARACEM UNIVERSAL DC. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Coltene/Whaledent AG (New York, US). The FDA issued a Cleared decision on November 9, 2005 after a review of 13 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 Coltene/Whaledent AG devices

Submission Details

510(k) Number K053040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2005
Decision Date November 09, 2005
Days to Decision 13 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
114d faster than avg
Panel avg: 127d · This submission: 13d
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 255
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K053040.
BIFIX QM
K060894 · Voco GmbH · May 2006
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K060334 · Ultradent Products, Inc. · Feb 2006
TEMPBOND CLEAR WITH TRICLOSAN
K053565 · Sybron Dental Specialties, Inc. · Feb 2006
LCR
K052235 · 3M Company · Sep 2005
EUGENONE
K051952 · Scientific Pharmaceuticals, Inc. · Sep 2005
PREMIER TEMPORARY CEMENT
K051866 · Premier Dental Products Co. · Sep 2005