Cleared Traditional

K935436 - ALPHA-DENT GLASS IONOMER CEMENT

K935436 is the FDA 510(k) clearance for ALPHA-DENT GLASS IONOMER CEMENT by Wallace A. Erickson & Co.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K935436 · Wallace A. Erickson & Co. · Dental device
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Jun 1994
Decision
212d
Days
Class 2
Risk

K935436 is an FDA 510(k) clearance for the ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED. 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 June 10, 1994 after a review of 212 days - an extended review 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: 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 Wallace A. Erickson & Co. devices

Submission Details

510(k) Number K935436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1993
Decision Date June 10, 1994
Days to Decision 212 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
85d slower than avg
Panel avg: 127d · This submission: 212d
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 K935436.
NEW LUTING CEMENT MATERIAL (NLC)
K940914 · Dentsply Intl. · Aug 1994
DEOX, OXYGEN BARRIER VISCOUS SOLUTION
K941065 · Ultradent Products, Inc. · Jun 1994
ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT
K942596 · Wallace A. Erickson & Co. · Jun 1994
HY BOND, GLASIONOMER CX
K940122 · Shofu Dental Corp. · May 1994
MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)
K940459 · Dentsply Intl. · Apr 1994
GRANITEC IONOMER RESIN CEMENT
K940546 · Confi-Dental Products Co. · Apr 1994