Cleared Traditional

K930872 - ALPHA-DENT ROOT CANAL SEALER

Also marketed or referenced as:
WACH'S FORMULA

K930872 is the FDA 510(k) clearance for ALPHA-DENT ROOT CANAL SEALER by Wallace A. Erickson & Co.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K930872 · Wallace A. Erickson & Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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.

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 K930872.
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
PULPDENT EDTA PREPARATIONS
K932791 · Pulpdent Corp. · Sep 1993
ROOT CANAL FILLING CEMENT
K914325 · Confi-Dental Products Co. · Mar 1992
ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH
K896656 · Pulpdent Corp. · Feb 1990