Cleared Traditional

K031264 - PORTA PRESSOVER

K031264 is an FDA 510(k) clearance for PORTA PRESSOVER, 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 52-day FDA review.

K031264 · Wieland Dental + Technik GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
52d
Days
Class 2
Risk

K031264 is an FDA 510(k) clearance for the PORTA PRESSOVER. 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 June 12, 2003 after a review of 52 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 Dental + Technik GmbH & Co. KG devices

FDA 510(k) Submission Details - K031264

510(k) Number K031264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2003
Decision Date June 12, 2003
Days to Decision 52 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
75d faster than avg
Panel avg: 127d · This submission: 52d
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 549
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K031264.
ULTRACROWN 75 ALLOY
K032851 · Dentsply International · Sep 2003
R&D DESIGNATION AP-052-5
K032267 · Jensen Industries, Inc. · Sep 2003
ALEXANDER
K032493 · Ivoclar Vivadent, Inc. · Sep 2003
BIOUNIVERSAL PKF
K030435 · Ivoclar Vivadent, Inc. · Apr 2003
BIO UNIVERSAL
K030436 · Ivoclar Vivadent, Inc. · Apr 2003
PORTA IMPLANT
K030312 · Wieland Dental + Technik GmbH & Co. KG · Mar 2003