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FDA 510(k)

SURGICAL HANDPIECES, MIKRO SAW HANDPIECES

K-Number: K080939 · 2008-07-29

ApplicantW&H Dentalwerk Buermoos GmbH
Decision Date2008-07-29
Product CodeKMW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SURGICAL HANDPIECES, MIKRO SAW HANDPIECES is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2008-07-29 under 510(k) number K080939. The device is classified under product code KMW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL HANDPIECES, MIKRO SAW HANDPIECES?

SURGICAL HANDPIECES, MIKRO SAW HANDPIECES is a medical device that received FDA 510(k) clearance on 2008-07-29. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K080939.

When did SURGICAL HANDPIECES, MIKRO SAW HANDPIECES receive FDA 510(k) clearance?

SURGICAL HANDPIECES, MIKRO SAW HANDPIECES received FDA 510(k) clearance on 2008-07-29, under 510(k) number K080939.

Who is the listed applicant for SURGICAL HANDPIECES, MIKRO SAW HANDPIECES?

The FDA 510(k) record lists W&H Dentalwerk Buermoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL HANDPIECES, MIKRO SAW HANDPIECES?

The FDA product code for SURGICAL HANDPIECES, MIKRO SAW HANDPIECES is KMW.

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Other records listing W&H Dentalwerk Buermoos GmbH as applicant

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Related Devices (Code: KMW)

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.

K211584Oral Surgery ContraNakanishi, Inc.K171155Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc.K162544OsteoMed PINNACLE DriverOsteomedK994298FRIOS MICROSAWFriadent GmbHK971692OSTEOPOWER SYSTEM AND ACCESSORIESOsteomed Corp.K970953E-TYPE SPEED REDUCER CONTRA ANGLENsk Nakanishi, 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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