Cleared Traditional

K012843 - PORTADUR P 2, MODEL #2031

K012843 is an FDA 510(k) clearance for PORTADUR P 2, manufactured by Wieland Edelmetalle GmbH & Co.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K012843 · Wieland Edelmetalle GmbH & Co. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
71d
Days
Class 2
Risk

K012843 is an FDA 510(k) clearance for the PORTADUR P 2, MODEL #2031. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Wieland Edelmetalle GmbH & Co. (D-75179 Pforzheim, DE). The FDA issued a Cleared decision on November 2, 2001 after a review of 71 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 - K012843

510(k) Number K012843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2001
Decision Date November 02, 2001
Days to Decision 71 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
57d faster than avg
Panel avg: 128d · This submission: 71d
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 626
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K012843.
AUROPAL, ORDER-NO.: 2101
K012839 · Wieland Edelmetalle GmbH & Co. · Dec 2001
AUROFLUID PLUS
K013505 · Metalor Technologies USA · Dec 2001
HIGH GOLD PALLADIUM FREE CERAMIC SOLDER
K012877 · Ivoclar USA, Inc. · Nov 2001
BIOPORTA G, MODEL 2052
K012826 · Wieland Edelmetalle GmbH & Co. · Nov 2001
PORTA AURIUM, MODEL 2067
K012827 · Wieland Edelmetalle GmbH & Co. · Nov 2001
BIO PORTADUR, ORDER-NO.:2017
K012831 · Wieland Edelmetalle GmbH & Co. · Nov 2001
K012843 · PORTADUR P 2, MODEL #2031
Download PDF FDA Summary Wieland Edelmetalle G…