Cleared Traditional

K992176 - EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL

K992176 is an FDA 510(k) clearance for EXCEL ULTRA-HI FORMULA HEAT-CURED DENTU..., 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 227-day FDA review.

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

FDA 510(k) Submission Details - K992176

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
Combination Product No
PCCP Authorized No
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.

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 209
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K992176.
TRUBYTE DENTURE BASE RESIN SYSTEM
K011560 · Dentsply Intl. · Jul 2001
HARD RELINER
K011277 · S & C Polymer GmbH · Jun 2001
VERSYO.COM
K010800 · Heraeus Kulzer, Inc. · May 2001
UFI GEL HARD
K993827 · Voco GmbH · Jan 2000
ENIGMA HI-BASE DENTURE BASE MATERIAL
K993717 · Davis Schottlander & Davis, Ltd. · Dec 1999
MODIFICATION TO LINER II: SOFT RELINE LIQUID
K991687 · Bosworth Co. · Oct 1999