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FDA 510(k)

BRUIS Software Suite

K-Number: K191720 · 2020-04-17

ApplicantMechanodontics, Inc.
Decision Date2020-04-17
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRUIS Software Suite is the device name listed in this FDA 510(k) record. The listed applicant is Mechanodontics, Inc.. It received FDA 510(k) clearance on 2020-04-17 under 510(k) number K191720. 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 BRUIS Software Suite?

BRUIS Software Suite is a medical device that received FDA 510(k) clearance on 2020-04-17. The listed applicant is Mechanodontics, Inc.. The 510(k) number is K191720.

When did BRUIS Software Suite receive FDA 510(k) clearance?

BRUIS Software Suite received FDA 510(k) clearance on 2020-04-17, under 510(k) number K191720.

Who is the listed applicant for BRUIS Software Suite?

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

What is the FDA product code for BRUIS Software Suite?

The FDA product code for BRUIS Software Suite 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, LLCK253343Celebrace SoftwareCelebraceK250198Laon 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.

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