Cleared Traditional

K040524 - PORTA SOLDER 1090 W

K040524 is an FDA 510(k) clearance for PORTA SOLDER 1090 W, manufactured by Wieland Dental + Technik GmbH & Co. KG. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K040524 · Wieland Dental + Technik GmbH & Co. KG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
80d
Days
Class 2
Risk

K040524 is an FDA 510(k) clearance for the PORTA SOLDER 1090 W. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on May 20, 2004 after a review of 80 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.

FDA 510(k) Submission Details - K040524

510(k) Number K040524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2004
Decision Date May 20, 2004
Days to Decision 80 days
Submission Type Traditional
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
48d faster than avg
Panel avg: 128d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based 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 - EJT Alloy, Gold-based Noble Metal

All 624
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K040524.
PROMETAL HN86
K052463 · Prometal Technologies · Oct 2005
BIO 60
K041378 · Kodent, Inc. · Aug 2004
PORTA REFLEX
K040672 · Wieland Dental + Technik GmbH & Co. KG · May 2004
NDX-40 ALLOY
K040043 · Heraeus Kulzer, Inc. · Mar 2004
HERADOR EC, PF, C, H, NH, G, GG AND MP
K034049 · Heraeus Kulzer,GmbH · Mar 2004
GOLD DENTAL CASTING ALLOYS
K033279 · Bego U.S.A. · Jan 2004
K040524 · PORTA SOLDER 1090 W
Download PDF FDA Summary Wieland Dental + Tech…