Cleared Traditional

K140993 - IONOSTAR MOLAR

K140993 is an FDA 510(k) clearance for IONOSTAR MOLAR, manufactured by Voco GmbH. The device is a Class 2 Dental device with 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.

FDA 510(k) Submission Details - K140993

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
58d slower than avg
Panel avg: 128d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

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 470
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K140993.
PANAVIA SA Cement Plus Handmix
K142623 · Kuraray Noritake Dental, Inc. · Feb 2015
PANAVIA SA Cement Plus Automix
K142625 · Kuraray Noritake Dental, Inc. · Jan 2015
DENALI 501CEMENT
K141503 · Denali Corporation · Nov 2014
ESTEMP IMPLANT, ESTEMP CLEAR
K134021 · Spident Co., Ltd. · Jun 2014
CERCOM II CEMENT
K132393 · Denali Corporation · Mar 2014
ULTRACEM
K132255 · Ultradent Products Inc. / Oratech, LLC · Oct 2013
K140993 · IONOSTAR MOLAR
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