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FDA 510(k)

ARISTEE (RESIN, CROWN AND BRIDGES)

K-Number: K900068 · 1990-04-03

ApplicantPrometex, Inc.
Decision Date1990-04-03
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARISTEE (RESIN, CROWN AND BRIDGES) is the device name listed in this FDA 510(k) record. The listed applicant is Prometex, Inc.. It received FDA 510(k) clearance on 1990-04-03 under 510(k) number K900068. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARISTEE (RESIN, CROWN AND BRIDGES)?

ARISTEE (RESIN, CROWN AND BRIDGES) is a medical device that received FDA 510(k) clearance on 1990-04-03. The listed applicant is Prometex, Inc.. The 510(k) number is K900068.

When did ARISTEE (RESIN, CROWN AND BRIDGES) receive FDA 510(k) clearance?

ARISTEE (RESIN, CROWN AND BRIDGES) received FDA 510(k) clearance on 1990-04-03, under 510(k) number K900068.

Who is the listed applicant for ARISTEE (RESIN, CROWN AND BRIDGES)?

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

What is the FDA product code for ARISTEE (RESIN, CROWN AND BRIDGES)?

The FDA product code for ARISTEE (RESIN, CROWN AND BRIDGES) is EBG.

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 Prometex, 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.

K894484AUDIOTESTER SCREENING AUDIOMETERK892710ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)K872894A2J MZ 44 LASER LIGHT FOR POSITIONING

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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