Cleared Traditional

ENDOSEAL MTA (K170175) - FDA 510(k) Clearance

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

K170175 · Maruchi · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
403d
Days
Class 2
Risk

K170175 is an FDA 510(k) clearance for the 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 February 26, 2018 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Maruchi devices

Submission Details

510(k) Number K170175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2017
Decision Date February 26, 2018
Days to Decision 403 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
276d slower than avg
Panel avg: 127d · This submission: 403d
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 Consultant

LK Consulting Group USA, Inc.
Priscilla Chung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K170175.
BIO-C TEMP
K180199 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2019
Sonendo Material A
K181922 · Sonendo, Inc. · Oct 2018
BIO-C REPAIR
K180185 · Angelus Industria DE Produtos Odontologicos S/A · Aug 2018
ENDOSOLV
K172839 · Septodont · Feb 2018
BIO-C SEALER
K172701 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2018
MTA MATERIAL II
K981620 · Dentsply Intl. · Jul 1998