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510(k) K181134

G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray by Sunstar Americas, Inc. — Product Code LFD

K181134 is an FDA 510(k) premarket notification submitted by Sunstar Americas, Inc. for the device "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 issued a decision of Substantially Equivalent on July 13, 2018. The device falls under product code LFD (Saliva, Artificial), a Class U device. Sunstar Americas, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2018
Date Received
April 30, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saliva, Artificial
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Sunstar Americas, Inc.

  • K132325 — GUIDOR BIORESORBABLE MATRIX BARRIER (October 29, 2013)
  • K102053 — BUTLER CALCI-FLOR PROPHYLAXIS PASTE (February 3, 2011)

Other clearances for product code LFD

  • K253778 — Allday Moisturizing Rinse (February 27, 2026)
  • K250390 — CloSYS® Dry Mouth Sensitive Mouth Rinse (May 19, 2025)
  • K240508 — Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) (April 19, 2024)
  • K234015 — Caphosol® Artifical Saliva (32 doses sachet box) (March 11, 2024)
  • K231205 — GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray (August 22, 2023)
  • K202689 — Dentilube Spray (September 3, 2021)
  • K203567 — Oral-B Dry Mouth Oral Rinse (April 5, 2021)
  • K201277 — Oral-B Dry Mouth Oral Rinse (September 2, 2020)
  • K181839 — CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray (November 21, 2019)
  • K190144 — MucoPEG (November 5, 2019)

FDA data resources