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FDA 510(k)

EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO

K-Number: K934019 · 1994-01-18

ApplicantSt. George Technology, Inc.
Decision Date1994-01-18
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO 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 1994-01-18 under 510(k) number K934019. 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 FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO?

EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO is a medical device that received FDA 510(k) clearance on 1994-01-18. The listed applicant is St. George Technology, Inc.. The 510(k) number is K934019.

When did EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO receive FDA 510(k) clearance?

EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO received FDA 510(k) clearance on 1994-01-18, under 510(k) number K934019.

Who is the listed applicant for EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO?

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 FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO?

The FDA product code for EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO is EBI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 MATERIALK945711EXCEL-P FORMULA AUTO-CURE DENTURE BASE

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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