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510(k) K040950

ALOCLAIR ORAL GEL by Sinclair Pharmaceuticals, Ltd. — Product Code OLR

K040950 is an FDA 510(k) premarket notification submitted by Sinclair Pharmaceuticals, Ltd. for the device "ALOCLAIR ORAL GEL". The FDA issued a decision of Substantially Equivalent on June 21, 2004. The device falls under product code OLR (Oral Wound Dressing), 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
June 21, 2004
Date Received
April 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oral Wound Dressing
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Other clearances by Sinclair Pharmaceuticals, Ltd.

  • K050158 — SINCLAIR SEBORRHEA EMULSION (October 11, 2006)
  • K042722 — ALOCLAIR ORAL SPRAY (January 13, 2005)
  • K024148 — SALINUM, ORCLAIR (September 15, 2003)
  • 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 OLR

  • K260126 — Curajel™ Oral Gel (June 15, 2026)
  • K253816 — MuCover (proposed name) Oral Wound Dressing (May 21, 2026)
  • K253758 — Dental Cone; Dental Sponge (December 18, 2025)
  • K252425 — Silatrix Oral Gel (October 23, 2025)
  • K241283 — Elemental Granulate (January 3, 2025)
  • K230529 — HealiAid Dental Collagen Wound Dressing (November 22, 2023)
  • K221428 — PerioStom Dental Dressing (December 22, 2022)
  • K211851 — Ora-Aid (January 11, 2022)
  • K210211 — PuraStat-OM (October 8, 2021)
  • K203091 — MucoLock Oral Gel (February 12, 2021)

FDA data resources