Cleared Traditional

K012835 - PORTA MAXIMUM, MODEL# 2066

K012835 is an FDA 510(k) clearance for PORTA MAXIMUM, 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 70-day FDA review.

K012835 · Wieland Edelmetalle GmbH & Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
70d
Days
Class 2
Risk

K012835 is an FDA 510(k) clearance for the PORTA MAXIMUM, MODEL# 2066. 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 1, 2001 after a review of 70 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 - K012835

510(k) Number K012835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2001
Decision Date November 01, 2001
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
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 550
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K012835.
AUTOPAL 50
K021733 · Wieland Dental + Technik GmbH & Co. KG · Jun 2002
PORTALLOY 54
K021242 · Wieland Dental + Technik GmbH & Co. KG · May 2002
PORTADUR P 4
K020190 · Wieland Dental + Technik GmbH & Co. KG · Mar 2002
GPW-SF
K011659 · Gateway Alloys, Inc. · Aug 2001
CONCORD 88
K011661 · Gateway Alloys, Inc. · Aug 2001
CONCORD 72
K011626 · Gateway Alloys, Inc. · Jul 2001