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FDA 510(k)

MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM

K-Number: K013659 · 2001-12-06

ApplicantSirona Dental Systems GmbH
Decision Date2001-12-06
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM 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 2001-12-06 under 510(k) number K013659. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM?

MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-06. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K013659.

When did MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM received FDA 510(k) clearance on 2001-12-06, under 510(k) number K013659.

Who is the listed applicant for MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM?

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 MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM?

The FDA product code for MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM is MUH.

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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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