Home / 510(k) Clearances / K163029

510(k) K163029

Hydris™ Oral Rinse by Biopharm Consult, LLC — Product Code LFD

K163029 is an FDA 510(k) premarket notification submitted by Biopharm Consult, LLC for the device "Hydris™ Oral Rinse". The FDA issued a decision of Substantially Equivalent on June 19, 2017. The device falls under product code LFD (Saliva, Artificial), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2017
Date Received
October 31, 2016
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

  • 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)
  • 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)

FDA data resources