Cleared Traditional

K960548 - AH PLUS ROOT CANAL SEALER

K960548 is the FDA 510(k) clearance for AH PLUS ROOT CANAL SEALER by Dentsply Intl.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K960548 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
78d
Days
Class 2
Risk

K960548 is an FDA 510(k) clearance for the AH PLUS ROOT CANAL SEALER. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on April 26, 1996 after a review of 78 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 Dentsply Intl. devices

Submission Details

510(k) Number K960548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1996
Decision Date April 26, 1996
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 81
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K960548.
SEALAPEX
K972369 · Sybron Dental Specialties, Inc. · Aug 1997
ENDO-SEAL
K971899 · Ultradent Products, Inc. · Jun 1997
ALPHA-DENT ROOT CANAL SEALER & FILLER
K963922 · Wallace A. Erickson & Co. · Dec 1996
CANAL KING (THIN) CANAL KING (THICK)
K940368 · Pulpdent Corp. · Jan 1995
PULPDENT ROOT CANAL SEALER
K946138 · Pulpdent Corp. · Jan 1995
TUBLI-SEAL EWT
K942393 · Sybron Dental Specialties, Inc. · Jun 1994