Cleared Traditional

K133042 - ENDOCEM ZR (FDA 510(k) Clearance)

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

K133042 · Maruchi · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
227d
Days
Class 2
Risk

K133042 is an FDA 510(k) clearance for the ENDOCEM ZR. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Maruchi (Fullerton, US). The FDA issued a Cleared decision on May 12, 2014 after a review of 227 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 K133042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2013
Decision Date May 12, 2014
Days to Decision 227 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 127d · This submission: 227d
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 142
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