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510(k) K181839

CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray by Oralabs, Inc. — Product Code LFD

K181839 is an FDA 510(k) premarket notification submitted by Oralabs, Inc. for the device "CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray". The FDA issued a decision of Substantially Equivalent on November 21, 2019. The device falls under product code LFD (Saliva, Artificial), a Class U device. Oralabs, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2019
Date Received
July 11, 2018
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 Oralabs, Inc.

  • K113326 — ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD (June 27, 2012)

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)
  • K190144 — MucoPEG (November 5, 2019)
  • K181194 — SmartMouth DryMouth Oral Rinse (February 15, 2019)

FDA data resources