Cleared Special

K080514 - PECD-01 AND PECD QUICK-01

K080514 is an FDA 510(k) clearance for PECD-01 AND PECD QUICK-01, manufactured by 3M Espe AG Dental Products. The device is a Class 2 Dental device with product code ELW cleared through the Special 510(k) pathway after a 30-day FDA review.

K080514 · 3M Espe AG Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
30d
Days
Class 2
Risk

K080514 is an FDA 510(k) clearance for the PECD-01 AND PECD QUICK-01. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by 3M Espe AG Dental Products (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on March 26, 2008 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all 3M Espe AG Dental Products devices

FDA 510(k) Submission Details - K080514

510(k) Number K080514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2008
Decision Date March 26, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 127d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 195
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K080514.
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VIRTUAL
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