510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181134Substantially Equivalent

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

Sunstar Americas, Inc., Schaumburg IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181134 is the FDA 510(k) clearance record 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, cleared for Sunstar Americas, Inc. on under FDA product code LFD (Saliva, Artificial). FDA records list 3 510(k) clearances for Sunstar Americas, Inc., from to . As of , FDA records show one recall naming K181134.

Clearance record

Decision date
Received
(74 days to decision)
Product code
LFD Saliva, Artificial
Device class
Unclassified
Review panel
Unknown
Applicant
Sunstar Americas, Inc. 301 E. Central Rd., Schaumburg IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFD

Trailing 12 months
1 clearance under product code LFD in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260