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FDA 510(k)

SmartMouth DryMouth Oral Rinse

K-Number: K181194 · 2019-02-15

ApplicantTriumph Pharmaceuticals, Inc.
Decision Date2019-02-15
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

SmartMouth DryMouth Oral Rinse is a medical device manufactured by Triumph Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2019-02-15 under approval number K181194. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartMouth DryMouth Oral Rinse?

SmartMouth DryMouth Oral Rinse is a medical device that received FDA 510(k) clearance on 2019-02-15. It is manufactured by Triumph Pharmaceuticals, Inc.. The 510(k) number is K181194.

When was SmartMouth DryMouth Oral Rinse approved by the FDA?

SmartMouth DryMouth Oral Rinse received FDA 510(k) clearance on 2019-02-15, under approval number K181194.

What company makes SmartMouth DryMouth Oral Rinse?

SmartMouth DryMouth Oral Rinse is manufactured by Triumph Pharmaceuticals, Inc..

What is the FDA product code for SmartMouth DryMouth Oral Rinse?

The FDA product code for SmartMouth DryMouth Oral Rinse is LFD.

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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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