Cleared Traditional

K151142 - IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K151142 · Wieland Dental + Technik GmbH & Co. KG · Dental device
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Aug 2015
Decision
106d
Days
Class 2
Risk

K151142 is an FDA 510(k) clearance for the IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on August 13, 2015 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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

Submission Details

510(k) Number K151142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2015
Decision Date August 13, 2015
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 327
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