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FDA 510(k)

IMPLANT HANDPIECES

K-Number: K051661 · 2005-09-06

ApplicantSirona Dental Systems GmbH
Decision Date2005-09-06
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPLANT HANDPIECES is the device name listed in this FDA 510(k) record. The listed applicant is Sirona Dental Systems GmbH. It received FDA 510(k) clearance on 2005-09-06 under 510(k) number K051661. 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 IMPLANT HANDPIECES?

IMPLANT HANDPIECES is a medical device that received FDA 510(k) clearance on 2005-09-06. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K051661.

When did IMPLANT HANDPIECES receive FDA 510(k) clearance?

IMPLANT HANDPIECES received FDA 510(k) clearance on 2005-09-06, under 510(k) number K051661.

Who is the listed applicant for IMPLANT HANDPIECES?

The FDA 510(k) record lists Sirona Dental Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLANT HANDPIECES?

The FDA product code for IMPLANT HANDPIECES 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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