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510(k) K231205

GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray by Gurunanda, LLC — Product Code LFD

K231205 is an FDA 510(k) premarket notification submitted by Gurunanda, LLC for the device "GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray". The FDA issued a decision of Substantially Equivalent on August 22, 2023. The device falls under product code LFD (Saliva, Artificial), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2023
Date Received
April 27, 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 for product code LFD

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  • 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)
  • 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