Cleared Traditional

EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL (K992176) - FDA 510(k) Clearance

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

K992176 · St. George Technology, Inc. · Dental device
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Feb 2000
Decision
227d
Days
Class 2
Risk

K992176 is an FDA 510(k) clearance for the EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL. 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 February 10, 2000 after a review of 227 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

Submission Details

510(k) Number K992176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1999
Decision Date February 10, 2000
Days to Decision 227 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
100d slower than avg
Panel avg: 127d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 79
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K992176.
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LIQCRYLIC PRO DENTAL RESIN
K972573 · Dentsply Intl. · Sep 1997
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K964040 · Dentsply Intl. · Dec 1996