510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253778Substantially Equivalent

Allday Moisturizing Rinse

Elevate Oral Care, LLC, West Palm Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253778 is the FDA 510(k) clearance record for Allday Moisturizing Rinse, cleared for Elevate Oral Care on under FDA product code LFD (Saliva, Artificial). FDA records list 5 510(k) clearances for Elevate Oral Care, from to . As of , FDA records show no recalls naming K253778.

Clearance record

Decision date
Received
(93 days to decision)
Product code
LFD Saliva, Artificial
Device class
Unclassified
Review panel
Unknown
Applicant
Elevate Oral Care 346 Pike Rd., West Palm Beach FL
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