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510(k) K024148

SALINUM, ORCLAIR by Sinclair Pharmaceuticals, Ltd. — Product Code LFD

K024148 is an FDA 510(k) premarket notification submitted by Sinclair Pharmaceuticals, Ltd. for the device "SALINUM, ORCLAIR". The FDA issued a decision of Substantially Equivalent on September 15, 2003. The device falls under product code LFD (Saliva, Artificial), a Class U device. Sinclair Pharmaceuticals, Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2003
Date Received
December 16, 2002
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 Sinclair Pharmaceuticals, Ltd.

  • K050158 — SINCLAIR SEBORRHEA EMULSION (October 11, 2006)
  • K042722 — ALOCLAIR ORAL SPRAY (January 13, 2005)
  • K040950 — ALOCLAIR ORAL GEL (June 21, 2004)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (July 28, 2003)
  • K023046 — SST SALIVA SUPPORTING TABLETS (December 2, 2002)
  • K023155 — ALOCLAIR ORAL RINSE (November 25, 2002)
  • K013056 — GELCLAIR CONCENTRATED ORAL GEL (December 21, 2001)

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