Cleared Traditional

K052820 - PARAPOST PARACORE AUTOMIX 5ML

K052820 is the FDA 510(k) clearance for PARAPOST PARACORE AUTOMIX 5ML by Coltene/Whaledent AG. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K052820 · Coltene/Whaledent AG · Dental device
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Jan 2006
Decision
97d
Days
Class 2
Risk

K052820 is an FDA 510(k) clearance for the PARAPOST PARACORE AUTOMIX 5ML. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Coltene/Whaledent AG (New York, US). The FDA issued a Cleared decision on January 9, 2006 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Coltene/Whaledent AG devices

Submission Details

510(k) Number K052820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2005
Decision Date January 09, 2006
Days to Decision 97 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
30d faster than avg
Panel avg: 127d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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.