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FDA 510(k)

SIDEXIS 4

K-Number: K132773 · 2013-12-11

ApplicantSirona Dental Systems GmbH
Decision Date2013-12-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIDEXIS 4 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 2013-12-11 under 510(k) number K132773. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIDEXIS 4?

SIDEXIS 4 is a medical device that received FDA 510(k) clearance on 2013-12-11. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K132773.

When did SIDEXIS 4 receive FDA 510(k) clearance?

SIDEXIS 4 received FDA 510(k) clearance on 2013-12-11, under 510(k) number K132773.

Who is the listed applicant for SIDEXIS 4?

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 SIDEXIS 4?

The FDA product code for SIDEXIS 4 is LLZ.

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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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