Cleared Traditional

ENDOSOLV (K172839) - FDA 510(k) Clearance

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

K172839 · Septodont · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
147d
Days
Class 2
Risk

K172839 is an FDA 510(k) clearance for the ENDOSOLV. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Septodont (Louisville, US). The FDA issued a Cleared decision on February 13, 2018 after a review of 147 days - within the typical 510(k) review window.

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 Septodont devices

Submission Details

510(k) Number K172839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2017
Decision Date February 13, 2018
Days to Decision 147 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
20d slower than avg
Panel avg: 127d · This submission: 147d
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 K172839.
Sonendo Material A
K181922 · Sonendo, Inc. · Oct 2018
BIO-C REPAIR
K180185 · Angelus Industria DE Produtos Odontologicos S/A · Aug 2018
ENDOSEAL MTA
K170175 · Maruchi · Feb 2018
BIO-C SEALER
K172701 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2018
MTA MATERIAL II
K981620 · Dentsply Intl. · Jul 1998
MTA MATERIAL
K980332 · Dentsply Intl. · Feb 1998