Cleared Traditional

K955089 - ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY...

K955089 is the FDA 510(k) clearance for ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY... by Wallace A. Erickson & Co.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K955089 · Wallace A. Erickson & Co. · Dental device
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Dec 1995
Decision
36d
Days
Class 2
Risk

K955089 is an FDA 510(k) clearance for the ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Wallace A. Erickson & Co. (Chicago, US). The FDA issued a Cleared decision on December 13, 1995 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 K955089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1995
Decision Date December 13, 1995
Days to Decision 36 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
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 286
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K955089.
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K962297 · Ivoclar North America, Inc. · Jun 1996
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K961584 · GC America, Inc. · May 1996
C & B METABOND (MODIFICATION)
K960464 · Parkell, Inc. · Feb 1996
OPTIBOND 2A PRECOAT
K955068 · Sybron Dental Specialties, Inc. · Dec 1995
PULPDENT RESILUTE
K955017 · Pulpdent Corp. · Dec 1995
NEXUS
K954762 · Sybron Dental Specialties, Inc. · Nov 1995