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FDA 510(k)

G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray

K-Number: K181134 · 2018-07-13

ApplicantSunstar Americas, Inc.
Decision Date2018-07-13
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray is a medical device manufactured by Sunstar Americas, Inc.. It received FDA 510(k) clearance on 2018-07-13 under approval number K181134. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray?

G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray is a medical device that received FDA 510(k) clearance on 2018-07-13. It is manufactured by Sunstar Americas, Inc.. The 510(k) number is K181134.

When was G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray approved by the FDA?

G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray received FDA 510(k) clearance on 2018-07-13, under approval number K181134.

What company makes G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray?

G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray is manufactured by Sunstar Americas, Inc..

What is the FDA product code for G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray?

The FDA product code for G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray 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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