Cleared Traditional

APEXIT ROOT CANAL SEALER (K893794) - FDA 510(k) Clearance

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

K893794 · Williams Dental Co., Inc. · Dental device
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Nov 1989
Decision
191d
Days
Class 2
Risk

K893794 is an FDA 510(k) clearance for the APEXIT ROOT CANAL SEALER. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Williams Dental Co., Inc. (Buffalo, US). The FDA issued a Cleared decision on November 29, 1989 after a review of 191 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 Williams Dental Co., Inc. devices

Submission Details

510(k) Number K893794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1989
Decision Date November 29, 1989
Days to Decision 191 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 127d · This submission: 191d
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.