Cleared Traditional

K103494 - ZENOSTAR MAGIC GLAZE

K103494 is the FDA 510(k) clearance for ZENOSTAR MAGIC GLAZE by Wieland Dental + Technik GmbH & Co. KG. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K103494 · Wieland Dental + Technik GmbH & Co. KG · Dental device
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Feb 2011
Decision
79d
Days
Class 2
Risk

K103494 is an FDA 510(k) clearance for the ZENOSTAR MAGIC GLAZE. 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 February 16, 2011 after a review of 79 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: 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 K103494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2010
Decision Date February 16, 2011
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 223
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K103494.
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