Cleared Traditional

K012840 - EURO 45, ORDER-NO.: 2064

K012840 is an FDA 510(k) clearance for EURO 45, manufactured by Wieland Edelmetalle GmbH & Co.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K012840 · Wieland Edelmetalle GmbH & Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
61d
Days
Class 2
Risk

K012840 is an FDA 510(k) clearance for the EURO 45, ORDER-NO.: 2064. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Wieland Edelmetalle GmbH & Co. (Pforzheim, DE). The FDA issued a Cleared decision on October 23, 2001 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 Wieland Edelmetalle GmbH & Co. devices

FDA 510(k) Submission Details - K012840

510(k) Number K012840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2001
Decision Date October 23, 2001
Days to Decision 61 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
66d faster than avg
Panel avg: 127d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

Product Code EJS Alloy, Other Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJS Alloy, Other Noble Metal

All 172
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K012840.
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