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FDA 510(k)

EXCEL-P FORMULA AUTO-CURE DENTURE BASE

K-Number: K945711 · 1995-02-02

ApplicantSt. George Technology, Inc.
Decision Date1995-02-02
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXCEL-P FORMULA AUTO-CURE DENTURE BASE 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 1995-02-02 under 510(k) number K945711. 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-P FORMULA AUTO-CURE DENTURE BASE?

EXCEL-P FORMULA AUTO-CURE DENTURE BASE is a medical device that received FDA 510(k) clearance on 1995-02-02. The listed applicant is St. George Technology, Inc.. The 510(k) number is K945711.

When did EXCEL-P FORMULA AUTO-CURE DENTURE BASE receive FDA 510(k) clearance?

EXCEL-P FORMULA AUTO-CURE DENTURE BASE received FDA 510(k) clearance on 1995-02-02, under 510(k) number K945711.

Who is the listed applicant for EXCEL-P FORMULA AUTO-CURE DENTURE BASE?

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-P FORMULA AUTO-CURE DENTURE BASE?

The FDA product code for EXCEL-P FORMULA AUTO-CURE DENTURE BASE is EBI.

Related Clinical Trials

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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 ANGLEK992176EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIALK934019EXCEL 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

View on FDA Database →

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

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