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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 a medical device manufactured by Mechanodontics, Inc.. It received FDA 510(k) clearance on 2020-04-17 under approval 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. It is manufactured by Mechanodontics, Inc.. The 510(k) number is K191720.

When was BRUIS Software Suite approved by the FDA?

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

What company makes BRUIS Software Suite?

BRUIS Software Suite is manufactured by Mechanodontics, Inc..

What is the FDA product code for BRUIS Software Suite?

The FDA product code for BRUIS Software Suite is PNN.

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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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