FDA 510(k)

Orchestrate 3D

K-Number: K181112 · 2018-11-26

Decision Date2018-11-26

Product CodePNN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Orchestrate 3D is the device name listed in this FDA 510(k) record. The listed applicant is Orchestrate 3D. It received FDA 510(k) clearance on 2018-11-26 under 510(k) number K181112. 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 Orchestrate 3D?

Orchestrate 3D is a medical device that received FDA 510(k) clearance on 2018-11-26. The listed applicant is Orchestrate 3D. The 510(k) number is K181112.

When did Orchestrate 3D receive FDA 510(k) clearance?

Orchestrate 3D received FDA 510(k) clearance on 2018-11-26, under 510(k) number K181112.

Who is the listed applicant for Orchestrate 3D?

The FDA 510(k) record lists Orchestrate 3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orchestrate 3D?

The FDA product code for Orchestrate 3D is PNN.

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, LLC K253343Celebrace SoftwareCelebrace K250198Laon OrthoLaon Medi, Inc.K241153Progressive Orthodontics AppProgressive Aligners, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.