Cleared Traditional

K934019 - EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO

K934019 is an FDA 510(k) clearance for EXCEL FORMULA HEAT-AUTO CURE DENT BASE/..., manufactured by St. George Technology, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K934019 · St. George Technology, Inc. · Dental device
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Jan 1994
Decision
154d
Days
Class 2
Risk

K934019 is an FDA 510(k) clearance for the EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by St. George Technology, Inc. (York, US). The FDA issued a Cleared decision on January 18, 1994 after a review of 154 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 St. George Technology, Inc. devices

FDA 510(k) Submission Details - K934019

510(k) Number K934019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1993
Decision Date January 18, 1994
Days to Decision 154 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
27d slower than avg
Panel avg: 127d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 210
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K934019.
COE-SOFT LC
K940565 · GC America, Inc. · May 1994
KOOLINER II
K935261 · GC America, Inc. · Jan 1994
REBARON LC
K930939 · GC America, Inc. · Jan 1994
ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER
K934248 · Wallace A. Erickson & Co. · Dec 1993
DUAL CURE RELINE MATERIAL
K926406 · Dentsply Intl. · Mar 1993
PALABOND
K924422 · Heraeus Kulzer, Inc. · Nov 1992