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FDA 510(k)

ORTHOPHOS 3/3 CEPH/3 DS

K-Number: K990528 · 1999-04-30

ApplicantSirona Dental Systems GmbH
Decision Date1999-04-30
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOPHOS 3/3 CEPH/3 DS 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 1999-04-30 under 510(k) number K990528. 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 ORTHOPHOS 3/3 CEPH/3 DS?

ORTHOPHOS 3/3 CEPH/3 DS is a medical device that received FDA 510(k) clearance on 1999-04-30. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K990528.

When did ORTHOPHOS 3/3 CEPH/3 DS receive FDA 510(k) clearance?

ORTHOPHOS 3/3 CEPH/3 DS received FDA 510(k) clearance on 1999-04-30, under 510(k) number K990528.

Who is the listed applicant for ORTHOPHOS 3/3 CEPH/3 DS?

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 ORTHOPHOS 3/3 CEPH/3 DS?

The FDA product code for ORTHOPHOS 3/3 CEPH/3 DS is MUH.

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Related Devices (Code: 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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