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FDA 510(k)

ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD

K-Number: K013650 · 2001-12-06

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

Device Summary

ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD 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 K013650. 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 DS/DC CEPH, ORTHOPHOS 5/PLUS/CD?

ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD 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 K013650.

When did ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD receive FDA 510(k) clearance?

ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD received FDA 510(k) clearance on 2001-12-06, under 510(k) number K013650.

Who is the listed applicant for ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD?

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 DS/DC CEPH, ORTHOPHOS 5/PLUS/CD?

The FDA product code for ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD 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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