Cleared Traditional

K120013 - TEMPSPAN CLEAR MATRIX

K120013 is an FDA 510(k) clearance for TEMPSPAN CLEAR MATRIX, manufactured by Pentron Clinical. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K120013 · Pentron Clinical · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
140d
Days
Class 2
Risk

K120013 is an FDA 510(k) clearance for the TEMPSPAN CLEAR MATRIX. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Pentron Clinical (Orange, US). The FDA issued a Cleared decision on May 22, 2012 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Pentron Clinical devices

FDA 510(k) Submission Details - K120013

510(k) Number K120013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2012
Decision Date May 22, 2012
Days to Decision 140 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
13d slower than avg
Panel avg: 127d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 247
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