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FDA 510(k)

SIROENDO

K-Number: K052515 · 2006-03-31

ApplicantSirona Dental Systems GmbH
Decision Date2006-03-31
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIROENDO 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 2006-03-31 under 510(k) number K052515. 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 SIROENDO?

SIROENDO is a medical device that received FDA 510(k) clearance on 2006-03-31. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K052515.

When did SIROENDO receive FDA 510(k) clearance?

SIROENDO received FDA 510(k) clearance on 2006-03-31, under 510(k) number K052515.

Who is the listed applicant for SIROENDO?

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 SIROENDO?

The FDA product code for SIROENDO 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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