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FDA 510(k)

SIRONA DENTAL CAD/CAM SYSTEM

K-Number: K111421 · 2012-02-17

ApplicantSirona Dental Systems GmbH
Decision Date2012-02-17
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIRONA DENTAL CAD/CAM 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 2012-02-17 under 510(k) number K111421. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIRONA DENTAL CAD/CAM SYSTEM?

SIRONA DENTAL CAD/CAM SYSTEM is a medical device that received FDA 510(k) clearance on 2012-02-17. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K111421.

When did SIRONA DENTAL CAD/CAM SYSTEM receive FDA 510(k) clearance?

SIRONA DENTAL CAD/CAM SYSTEM received FDA 510(k) clearance on 2012-02-17, under 510(k) number K111421.

Who is the listed applicant for SIRONA DENTAL CAD/CAM 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 SIRONA DENTAL CAD/CAM SYSTEM?

The FDA product code for SIRONA DENTAL CAD/CAM SYSTEM is NHA.

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Related Devices (Code: NHA)

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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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