Cleared Traditional

K080182 - ZENO PMMA DISC

K080182 is the FDA 510(k) clearance for ZENO PMMA DISC by Wieland Dental + Technik GmbH & Co. KG. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K080182 · Wieland Dental + Technik GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
74d
Days
Class 2
Risk

K080182 is an FDA 510(k) clearance for the ZENO PMMA DISC. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on April 8, 2008 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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

Submission Details

510(k) Number K080182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2008
Decision Date April 08, 2008
Days to Decision 74 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
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 87
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K080182.
TELIO CAD
K093708 · Ivoclar Vivadent, Inc. · Mar 2010
TEMPORARY C&B COMPOSITE
K091894 · Voco GmbH · Jul 2009
UNIFAST III
K073106 · GC America, Inc. · Apr 2008
PRO-V
K073263 · Bisco, Inc. · Feb 2008
SYSTEMP.C&B PLUS
K042820 · Ivoclar Vivadent, Inc. · Dec 2004
PROVISO
K041886 · Scientific Pharmaceuticals, Inc. · Aug 2004