Cleared Traditional

K082257 - ZENO AI ECO DISC

K082257 is an FDA 510(k) clearance for ZENO AI ECO DISC, manufactured by Wieland Dental + Technik GmbH & Co. KG. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K082257 · Wieland Dental + Technik GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
41d
Days
Class 2
Risk

K082257 is an FDA 510(k) clearance for the ZENO AI ECO DISC. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on September 18, 2008 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Wieland Dental + Technik GmbH & Co. KG devices

FDA 510(k) Submission Details - K082257

510(k) Number K082257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2008
Decision Date September 18, 2008
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 341
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K082257.
BELLUS SHADING KIT
K090718 · 3M Espe AG Dental Products · Sep 2009
QUATTRO PORCELAIN SYSTEM
K091706 · Dentsply International, Inc. · Aug 2009
GC AADVA ZR DISK
K082740 · GC America, Inc. · Nov 2008
VINTAGE ART
K080834 · Shofu Dental Corp. · Jun 2008
DENTAL CERAMIC
K080479 · Dmg USA, Inc. · May 2008
ZENO ZR DISC
K073108 · Wieland Dental + Technik GmbH & Co. KG · Nov 2007