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FDA 510(k)

EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL

K-Number: K992176 · 2000-02-10

ApplicantSt. George Technology, Inc.
Decision Date2000-02-10
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is St. George Technology, Inc.. It received FDA 510(k) clearance on 2000-02-10 under 510(k) number K992176. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL?

EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL is a medical device that received FDA 510(k) clearance on 2000-02-10. The listed applicant is St. George Technology, Inc.. The 510(k) number is K992176.

When did EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL receive FDA 510(k) clearance?

EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL received FDA 510(k) clearance on 2000-02-10, under 510(k) number K992176.

Who is the listed applicant for EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL?

The FDA 510(k) record lists St. George Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL?

The FDA product code for EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL is EBI.

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Other records listing St. George Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K023953ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLEK945711EXCEL-P FORMULA AUTO-CURE DENTURE BASEK934019EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO

Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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