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FDA 510(k)

MINIDAM

K-Number: K921117 · 1992-05-05

ApplicantDelsan Dental Systems
Decision Date1992-05-05
Product CodeDYN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINIDAM is the device name listed in this FDA 510(k) record. The listed applicant is Delsan Dental Systems. It received FDA 510(k) clearance on 1992-05-05 under 510(k) number K921117. 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 MINIDAM?

MINIDAM is a medical device that received FDA 510(k) clearance on 1992-05-05. The listed applicant is Delsan Dental Systems. The 510(k) number is K921117.

When did MINIDAM receive FDA 510(k) clearance?

MINIDAM received FDA 510(k) clearance on 1992-05-05, under 510(k) number K921117.

Who is the listed applicant for MINIDAM?

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

What is the FDA product code for MINIDAM?

The FDA product code for MINIDAM 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 Delsan Dental Systems 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.

K921771MINIDAM II

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 EJECTORTerraflexK935616SALIVA EJECTOR DISPOSABLEAsa Instruments S.R.L.K935758HYGOFLEX SALIVA-EJECTORJ.H.Orsing ABK924211EJECTORGlenroe TechnologiesK920492HIGH VACHygoplastic, Inc.K900631SALIVA 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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