Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SOPHOS DENTAL DIAMOND

K-Number: K943841 · 1994-09-16

ApplicantSophos Technologic
Decision Date1994-09-16
Product CodeDZP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOPHOS DENTAL DIAMOND is the device name listed in this FDA 510(k) record. The listed applicant is Sophos Technologic. It received FDA 510(k) clearance on 1994-09-16 under 510(k) number K943841. The device is classified under product code DZP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPHOS DENTAL DIAMOND?

SOPHOS DENTAL DIAMOND is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is Sophos Technologic. The 510(k) number is K943841.

When did SOPHOS DENTAL DIAMOND receive FDA 510(k) clearance?

SOPHOS DENTAL DIAMOND received FDA 510(k) clearance on 1994-09-16, under 510(k) number K943841.

Who is the listed applicant for SOPHOS DENTAL DIAMOND?

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

What is the FDA product code for SOPHOS DENTAL DIAMOND?

The FDA product code for SOPHOS DENTAL DIAMOND is DZP.

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: DZP)

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.

K120037BLUWHITE DIAMOND DENTAL BURS MODIFIEDBeavers Dental, Div. Sybron Canada, Ltd.K940908DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURSDunhall Pharmaceuticals, Inc.K934981DENTAL DRILLEare Consulting ServiceK923757DENTAL DIAMOND DRILLSAlpha Industrializacao DE Metais Ltda.K913651MANI DIA-BURSThe Lahr Consulting Group, Inc.K901967DENDIA WERK BURS AND CUTTING DISCSMicro-Aire Surgical Instruments, 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.

↑