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FDA 510(k)

DENDIA WERK BURS AND CUTTING DISCS

K-Number: K901967 · 1990-07-13

ApplicantMicro-Aire Surgical Instruments, Inc.
Decision Date1990-07-13
Product CodeDZP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENDIA WERK BURS AND CUTTING DISCS is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Aire Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1990-07-13 under 510(k) number K901967. 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 DENDIA WERK BURS AND CUTTING DISCS?

DENDIA WERK BURS AND CUTTING DISCS is a medical device that received FDA 510(k) clearance on 1990-07-13. The listed applicant is Micro-Aire Surgical Instruments, Inc.. The 510(k) number is K901967.

When did DENDIA WERK BURS AND CUTTING DISCS receive FDA 510(k) clearance?

DENDIA WERK BURS AND CUTTING DISCS received FDA 510(k) clearance on 1990-07-13, under 510(k) number K901967.

Who is the listed applicant for DENDIA WERK BURS AND CUTTING DISCS?

The FDA 510(k) record lists Micro-Aire Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENDIA WERK BURS AND CUTTING DISCS?

The FDA product code for DENDIA WERK BURS AND CUTTING DISCS is DZP.

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Other records listing Micro-Aire Surgical Instruments, 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.

K904949A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERSK903713OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229K902676MICROGUARD, ORTHOPEDIC PIN PROTECTORSK903650OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305K903664MICRO-AIRE WIRE PASS AND CRANIOTOME DRILLK901735ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444

View all 40 devices →

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 TechnologicK940908DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURSDunhall Pharmaceuticals, Inc.K934981DENTAL DRILLEare Consulting ServiceK923757DENTAL DIAMOND DRILLSAlpha Industrializacao DE Metais Ltda.K913651MANI DIA-BURSThe Lahr Consulting Group, 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.

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