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FDA 510(k)

SILIVA EJECTOR/ORAL CAVITY EVACUATOR

K-Number: K864300 · 1986-11-24

ApplicantArdent Intl., Inc.
Decision Date1986-11-24
Product CodeDYN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILIVA EJECTOR/ORAL CAVITY EVACUATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ardent Intl., Inc.. It received FDA 510(k) clearance on 1986-11-24 under 510(k) number K864300. The device is classified under product code DYN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILIVA EJECTOR/ORAL CAVITY EVACUATOR?

SILIVA EJECTOR/ORAL CAVITY EVACUATOR is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is Ardent Intl., Inc.. The 510(k) number is K864300.

When did SILIVA EJECTOR/ORAL CAVITY EVACUATOR receive FDA 510(k) clearance?

SILIVA EJECTOR/ORAL CAVITY EVACUATOR received FDA 510(k) clearance on 1986-11-24, under 510(k) number K864300.

Who is the listed applicant for SILIVA EJECTOR/ORAL CAVITY EVACUATOR?

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

What is the FDA product code for SILIVA EJECTOR/ORAL CAVITY EVACUATOR?

The FDA product code for SILIVA EJECTOR/ORAL CAVITY EVACUATOR is DYN.

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 Ardent Intl., 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.

K842512EXACTA-FILMK832647ARTICULATING PAPER

Related Devices (Code: DYN)

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.

K940769DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTORTerraflexK935758HYGOFLEX SALIVA-EJECTORJ.H.Orsing ABK935616SALIVA EJECTOR DISPOSABLEAsa Instruments S.R.L.K924211EJECTORGlenroe TechnologiesK920492HIGH VACHygoplastic, Inc.K921117MINIDAMDelsan Dental Systems

Official Source

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

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