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FDA 510(k)

CEREC Ortho Software

K-Number: K171122 · 2018-01-11

ApplicantDentsply Sirona
Decision Date2018-01-11
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CEREC Ortho Software is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K171122. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEREC Ortho Software?

CEREC Ortho Software is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Dentsply Sirona. The 510(k) number is K171122.

When did CEREC Ortho Software receive FDA 510(k) clearance?

CEREC Ortho Software received FDA 510(k) clearance on 2018-01-11, under 510(k) number K171122.

Who is the listed applicant for CEREC Ortho Software?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEREC Ortho Software?

The FDA product code for CEREC Ortho Software is PNN.

Other records listing Dentsply Sirona as applicant

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Related Devices (Code: PNN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd.K253565SureSmile SoftwareDentsply Sirona, Inc.K252507SmileInspectorAmv Consulting, LLCK253343Celebrace SoftwareCelebraceK250198Laon OrthoLaon Medi, Inc.K241153Progressive Orthodontics AppProgressive Aligners, Inc.

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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