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510(k) K240508

Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) by Laclede, Inc. — Product Code LFD

K240508 is an FDA 510(k) premarket notification submitted by Laclede, Inc. for the device "Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)". The FDA issued a decision of Substantially Equivalent on April 19, 2024. The device falls under product code LFD (Saliva, Artificial), a Class U device. Laclede, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2024
Date Received
February 21, 2024
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 Laclede, Inc.

  • K180680 — Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray (October 11, 2018)
  • K162235 — LUVENA VAGINAL MOISTURIZER & LUBRICANT (March 24, 2017)
  • K150841 — Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant (December 29, 2015)
  • K061331 — ORAL BALANCE LIQUID/ GEL (July 25, 2006)

Other clearances for product code LFD

  • K253778 — Allday Moisturizing Rinse (February 27, 2026)
  • K250390 — CloSYS® Dry Mouth Sensitive Mouth Rinse (May 19, 2025)
  • 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