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FDA 510(k)

DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR

K-Number: K940769 · 1994-08-17

ApplicantTerraflex
Decision Date1994-08-17
Product CodeDYN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Terraflex. It received FDA 510(k) clearance on 1994-08-17 under 510(k) number K940769. 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 DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR?

DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR is a medical device that received FDA 510(k) clearance on 1994-08-17. The listed applicant is Terraflex. The 510(k) number is K940769.

When did DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR receive FDA 510(k) clearance?

DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR received FDA 510(k) clearance on 1994-08-17, under 510(k) number K940769.

Who is the listed applicant for DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR?

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

What is the FDA product code for DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR?

The FDA product code for DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR 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

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.

K935616SALIVA EJECTOR DISPOSABLEAsa Instruments S.R.L.K935758HYGOFLEX SALIVA-EJECTORJ.H.Orsing ABK924211EJECTORGlenroe TechnologiesK920492HIGH VACHygoplastic, Inc.K921117MINIDAMDelsan Dental SystemsK900631SALIVA ABSORBER - DENTALKab Gloves Unltd.

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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