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

FDA 510(k) K181134 · Sunstar Americas, Inc.

Substantially Equivalent

510(k) numberK181134

Submission

Device name
G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray
Applicant
Sunstar Americas, Inc.
Schaumburg, IL, US
Received
April 30, 2018
Decision date
July 13, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LFD – Saliva, Artificial
Device class
Unclassified

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K234015Caphosol® Artifical Saliva (32 doses sachet box)LFD · Traditional Eusa Pharma (Uk) Limited03/11/2024SE
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K202689Dentilube SprayLFD · Traditional Oxy2plus, LLC09/03/2021SE
K203567Oral-B Dry Mouth Oral RinseLFD · Traditional The Procter & Gamble Company04/05/2021SE
K201277Oral-B Dry Mouth Oral RinseLFD · Traditional The Procter & Gamble Company09/02/2020SE
K181839CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayLFD · Traditional Oralabs, Inc.11/21/2019SE
K190144MucoPEGLFD · Traditional Sunbio, Inc.11/05/2019SE

More from Sunbio, Inc.

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Questions and answers

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 cleared 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 (K181134) received a 510(k) decision of Substantially Equivalent on July 13, 2018, 74 days after the submission was received.

What is the product code of K181134?

The FDA product code is LFD – Saliva, Artificial, a Unclassified device.