Cleared Traditional

White ENDOSEAL MTA (K202015) - FDA 510(k) Clearance

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

K202015 · Maruchi · Dental device
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Mar 2021
Decision
246d
Days
Class 2
Risk

K202015 is an FDA 510(k) clearance for the White ENDOSEAL MTA. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Maruchi (Wonju-Si, KR). The FDA issued a Cleared decision on March 24, 2021 after a review of 246 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 Maruchi devices

Submission Details

510(k) Number K202015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2020
Decision Date March 24, 2021
Days to Decision 246 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 127d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 58
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K202015.
Metapaste Plus
K210904 · Meta Biomed Co., Ltd. · Jun 2021
Metapex Plus
K202617 · Meta Biomed Co., Ltd. · Apr 2021
DiaPaste
K210333 · DiaDent Group International · Mar 2021
EDS Bioceramic Sealer (Bioseal)
K202281 · Essential Dental Systems · Feb 2021
Bio-C Repair Ion+
K201222 · Angelus Industria DE Produtos Odontologicos S/A · Feb 2021
DIA-ROOT BIO MTA
K200174 · DiaDent Group International · Sep 2020