Cleared Traditional

K130421 - MERON APPLICATION CAPSULES

K130421 is an FDA 510(k) clearance for MERON APPLICATION CAPSULES, 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 175-day FDA review.

K130421 · Voco GmbH · Dental device
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Aug 2013
Decision
175d
Days
Class 2
Risk

K130421 is an FDA 510(k) clearance for the MERON APPLICATION CAPSULES. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on August 14, 2013 after a review of 175 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 - K130421

510(k) Number K130421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2013
Decision Date August 14, 2013
Days to Decision 175 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
47d slower than avg
Panel avg: 128d · This submission: 175d
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 475
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K130421.
CERCOM II CEMENT
K132393 · Denali Corporation · Mar 2014
ULTRACEM
K132255 · Ultradent Products Inc. / Oratech, LLC · Oct 2013
MULTILINK HYBRID ABUTMENT CEMENT
K130436 · Ivoclar Vivadent, AG · Aug 2013
PROVITEMP
K122551 · Itena Clinical · Jun 2013
TRYOUT-VPS HOLDING PASTE
K122974 · Crown Delta Corp. · May 2013
DENTO TEMP
K122549 · Itena Clinical · Apr 2013
K130421 · MERON APPLICATION CAPSULES
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