Cleared Traditional

K140993 - IONOSTAR MOLAR

K140993 is the FDA 510(k) clearance for IONOSTAR MOLAR by Voco GmbH. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K140993 · Voco GmbH · Dental device
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Oct 2014
Decision
186d
Days
Class 2
Risk

K140993 is an FDA 510(k) clearance for the IONOSTAR MOLAR. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on October 20, 2014 after a review of 186 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Voco GmbH devices

Submission Details

510(k) Number K140993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2014
Decision Date October 20, 2014
Days to Decision 186 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
59d slower than avg
Panel avg: 127d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 183
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K143212 · Voco GmbH · May 2015
MERON APPLICATION CAPSULES
K130421 · Voco GmbH · Aug 2013
GAM-200
K120243 · GC America, Inc. · Jun 2012
PERMASHADE VENEER CEMENT
K111836 · Ultradent Products, Inc. · Sep 2011