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Excel Ultra-Hi Formula Heat-Cured Denture Base Material

by St. George Technology, Inc.

510(k) K992176

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992176 Date10 Feb 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EBI
Device Class
Class II
Regulation
21 CFR Part 872.3760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Excel Ultra-Hi Formula Heat-Cured Denture Base Material is a heat-cured denture base material that provides high impact protection and exceptional flexural strength. It is designed to withstand vigorous chewing and accidental drops while maintaining a natural and aesthetically pleasing appearance. This material is intended for use in the fabrication of denture bases.

The Excel Ultra-Hi Formula Heat-Cured Denture Base Material is supplied as a heat-curable material that offers superior workability with a quick cure option. It is manufactured by St. George Technology, Inc. and has received FDA 510(k) clearance with the product code EBI. The material is available in various sizes and is designed for laboratory use by dental technicians.

Other devices from St. George Technology, Inc.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Excel Ultra-Hi Formula Heat-Cured Denture Base Material used for?

    Excel Ultra-Hi Formula Heat-Cured Denture Base Material is designed for the fabrication of denture bases, providing high impact protection and exceptional flexural strength to withstand vigorous chewing and accidental drops while maintaining a natural appearance.

  • How is Excel Ultra-Hi Formula Heat-Cured Denture Base Material supplied?

    The material is supplied as a heat-curable denture base material that offers superior workability with a quick cure option, available in various sizes specifically designed for laboratory use by dental technicians.

  • What regulatory approvals does Excel Ultra-Hi Formula Heat-Cured Denture Base Material have?

    Excel Ultra-Hi Formula Heat-Cured Denture Base Material has received FDA 510(k) clearance with the product code EBI, classified as substantially equivalent under the advisory committee for dental devices.

  • Is Excel Ultra-Hi Formula Heat-Cured Denture Base Material suitable for single-use or multiple applications?

    The material is designed for laboratory use in the fabrication of denture bases, which are typically custom-made for individual patients and intended for long-term use rather than single-use applications.