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FDA 510(k)

ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)

K-Number: K892710 · 1989-10-24

ApplicantPrometex, Inc.
Decision Date1989-10-24
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARISTEE (TEMPORARY CROWN & BRIDGE RESIN) is the device name listed in this FDA 510(k) record. The listed applicant is Prometex, Inc.. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K892710. 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 (TEMPORARY CROWN & BRIDGE RESIN)?

ARISTEE (TEMPORARY CROWN & BRIDGE RESIN) is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Prometex, Inc.. The 510(k) number is K892710.

When did ARISTEE (TEMPORARY CROWN & BRIDGE RESIN) receive FDA 510(k) clearance?

ARISTEE (TEMPORARY CROWN & BRIDGE RESIN) received FDA 510(k) clearance on 1989-10-24, under 510(k) number K892710.

Who is the listed applicant for ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)?

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 (TEMPORARY CROWN & BRIDGE RESIN)?

The FDA product code for ARISTEE (TEMPORARY CROWN & BRIDGE RESIN) 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 AUDIOMETERK900068ARISTEE (RESIN, CROWN AND BRIDGES)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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