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510(k) K234015

Caphosol® Artifical Saliva (32 doses sachet box) by Eusa Pharma (Uk) Limited — Product Code LFD

K234015 is an FDA 510(k) premarket notification submitted by Eusa Pharma (Uk) Limited for the device "Caphosol® Artifical Saliva (32 doses sachet box)". The FDA issued a decision of Substantially Equivalent on March 11, 2024. The device falls under product code LFD (Saliva, Artificial), a Class U device. Eusa Pharma (Uk) Limited has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2024
Date Received
December 19, 2023
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 Eusa Pharma (Uk) Limited

  • K162167 — Caphosol Artifical Saliva Tablets (March 31, 2017)

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)
  • 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