Cleared Traditional

ACROSEAL ROOT CANAL OR APICAL SEALER (K023976) - FDA 510(k) Clearance

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

K023976 · Septodont S.A.S. · Dental device
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Jan 2003
Decision
64d
Days
Class 2
Risk

K023976 is an FDA 510(k) clearance for the ACROSEAL ROOT CANAL OR APICAL SEALER. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Septodont S.A.S. (Washington, US). The FDA issued a Cleared decision on January 30, 2003 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Septodont S.A.S. devices

Submission Details

510(k) Number K023976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2002
Decision Date January 30, 2003
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 127d · This submission: 64d
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 59
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K023976.
ENDOSEAL MTA
K170175 · Maruchi · Feb 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
MTA MATERIAL
K980332 · Dentsply Intl. · Feb 1998
AH PLUS ROOT CANAL SEALER
K960548 · Dentsply Intl. · Apr 1996