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FDA 510(k)

DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS

K-Number: K940908 · 1994-08-29

ApplicantDunhall Pharmaceuticals, Inc.
Decision Date1994-08-29
Product CodeDZP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS is the device name listed in this FDA 510(k) record. The listed applicant is Dunhall Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1994-08-29 under 510(k) number K940908. 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 DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS?

DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS is a medical device that received FDA 510(k) clearance on 1994-08-29. The listed applicant is Dunhall Pharmaceuticals, Inc.. The 510(k) number is K940908.

When did DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS receive FDA 510(k) clearance?

DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS received FDA 510(k) clearance on 1994-08-29, under 510(k) number K940908.

Who is the listed applicant for DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS?

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

What is the FDA product code for DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS?

The FDA product code for DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS is DZP.

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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.K943841SOPHOS DENTAL DIAMONDSophos TechnologicK934981DENTAL 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

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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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