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510(k) K253778

Allday Moisturizing Rinse by Elevate Oral Care — Product Code LFD

K253778 is an FDA 510(k) premarket notification submitted by Elevate Oral Care for the device "Allday Moisturizing Rinse". The FDA issued a decision of Substantially Equivalent on February 27, 2026. The device falls under product code LFD (Saliva, Artificial), a Class U device. Elevate Oral Care has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2026
Date Received
November 26, 2025
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 Elevate Oral Care

  • K233768 — Papacarie Duo (July 18, 2024)
  • K222323 — Black Diamond (June 23, 2023)
  • K150074 — Elevate Moisturizing Spray (June 19, 2015)
  • K131376 — SMARTCOAT 2.5% NAF VARNISH (August 27, 2013)

Other clearances for product code LFD

  • 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)
  • K181194 — SmartMouth DryMouth Oral Rinse (February 15, 2019)

FDA data resources