Cleared Traditional

ALPHA-DENT ROOT CANAL SEALER (K930872) - FDA 510(k) Clearance

Also marketed or referenced as:
WACH'S FORMULA

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

K930872 · Wallace A. Erickson & Co. · Dental device
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Feb 1994
Decision
347d
Days
Class 2
Risk

K930872 is an FDA 510(k) clearance for the ALPHA-DENT ROOT CANAL SEALER. 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 February 1, 1994 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Wallace A. Erickson & Co. devices

Submission Details

510(k) Number K930872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1993
Decision Date February 01, 1994
Days to Decision 347 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
220d slower than avg
Panel avg: 127d · This submission: 347d
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.