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FDA 510(k)

CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR

K-Number: K090931 · 2009-12-15

ApplicantW&H Dentalwerk Buermoos GmbH
Decision Date2009-12-15
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR 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 2009-12-15 under 510(k) number K090931. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR?

CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR is a medical device that received FDA 510(k) clearance on 2009-12-15. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K090931.

When did CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR receive FDA 510(k) clearance?

CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR received FDA 510(k) clearance on 2009-12-15, under 510(k) number K090931.

Who is the listed applicant for CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR?

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 CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR?

The FDA product code for CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR is EKX.

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Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

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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