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510(k) K061331

ORAL BALANCE LIQUID/ GEL by Laclede, Inc. — Product Code LFD

K061331 is an FDA 510(k) premarket notification submitted by Laclede, Inc. for the device "ORAL BALANCE LIQUID/ GEL". The FDA issued a decision of Substantially Equivalent on July 25, 2006. 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
July 25, 2006
Date Received
May 12, 2006
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.

  • K240508 — Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) (April 19, 2024)
  • 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)

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