Cleared Traditional

ALPHA-DENT ROOT CANAL SEALER & FILLER (K963922) - FDA 510(k) Clearance

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

K963922 · Wallace A. Erickson & Co. · Dental device
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Dec 1996
Decision
67d
Days
Class 2
Risk

K963922 is an FDA 510(k) clearance for the ALPHA-DENT ROOT CANAL SEALER & FILLER. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Wallace A. Erickson & Co. (Chicago, US). The FDA issued a Cleared decision on December 6, 1996 after a review of 67 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 Wallace A. Erickson & Co. devices

Submission Details

510(k) Number K963922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1996
Decision Date December 06, 1996
Days to Decision 67 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
60d faster than avg
Panel avg: 127d · This submission: 67d
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 K963922.
BIO-C SEALER
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AH PLUS ROOT CANAL SEALER
K960548 · Dentsply Intl. · Apr 1996
ROOT CANAL FILLING RESIN
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ROOT CANAL FILLING RESIN
K820284 · Dentsply Intl. · Mar 1982