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FDA 510(k)

VACUDENT LUMIX 65

K-Number: K800574 · 1980-05-20

ApplicantVacudent Sales Corp.
Decision Date1980-05-20
Product CodeEHP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VACUDENT LUMIX 65 is the device name listed in this FDA 510(k) record. The listed applicant is Vacudent Sales Corp.. It received FDA 510(k) clearance on 1980-05-20 under 510(k) number K800574. The device is classified under product code EHP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACUDENT LUMIX 65?

VACUDENT LUMIX 65 is a medical device that received FDA 510(k) clearance on 1980-05-20. The listed applicant is Vacudent Sales Corp.. The 510(k) number is K800574.

When did VACUDENT LUMIX 65 receive FDA 510(k) clearance?

VACUDENT LUMIX 65 received FDA 510(k) clearance on 1980-05-20, under 510(k) number K800574.

Who is the listed applicant for VACUDENT LUMIX 65?

The FDA 510(k) record lists Vacudent Sales Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VACUDENT LUMIX 65?

The FDA product code for VACUDENT LUMIX 65 is EHP.

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 Vacudent Sales Corp. 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.

K800575VACUDENT LUMIX 70K800520DENTAL STOOLS, #'S P2212, P1121, ETC.K781882MODULAT DENTAL SYSTEMS

Related Devices (Code: EHP)

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.

K022032ACETALInovativ, LLCK983558ACETAL DENTAL/PREFORMED CLASPDentamax, Inc.K974622DENTAL DMicro Dental LaboratoriesK955946ACETAL DENTAL/PREFORMED CLASPPressing DI Monticelli Rag. StefanoK954971ACETAL DENTAL/PREFORMED CLASPB & H Technical Services , Ltd.K854765INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETHC&C Systems, 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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