ALOCLAIR ORAL GEL— 510(k) K040950

Name: FDA 510(k) clearance K040950
Creator: U.S. Food and Drug Administration
Published: 2004-06-21

Substantially Equivalent

Sinclair Pharmaceuticals, Ltd.

FDA 510(k) clearance K040950 for ALOCLAIR ORAL GEL, Substantially Equivalent on 2004-06-21. Applicant: Sinclair Pharmaceuticals, Ltd.. Device class: Unclassified.

Clearance details

Applicant: Sinclair Pharmaceuticals, Ltd.
Product code: Code OLR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2004-04-12
Decision date: 2004-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrollton, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLR

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K251908 — Emanate Tray2026-07-29
K260126 — Curajel Oral Gel2026-06-15
K253816 — MuCover (proposed name) Oral Wound Dressing2026-05-21
K253758 — Dental Cone; Dental Sponge2025-12-18

More clearances from Sinclair Pharmaceuticals, Ltd.

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K050158 — SINCLAIR SEBORRHEA EMULSION2006-10-11
K042722 — ALOCLAIR ORAL SPRAY2005-01-13
K024148 — SALINUM, ORCLAIR2003-09-15
K024367 — SINCLAIR WOUND AND SKIN EMULSION2003-07-28
K023046 — SST SALIVA SUPPORTING TABLETS2002-12-02

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.