Data / Medical devices / United States / Alliance Pharma Inc.
Alliance Pharma Inc.: FDA-registered device maker in Cary, NC, United States, 3 510(k) clearances
Alliance Pharma Inc. is registered with the FDA (registration 3019867040) in Cary, NC, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 13, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019867040
- Address
- 11000 Regency Pkwy Suite 106, Cary, NC, United States, 27518
- Owner or operator
- Alliance Pharma Inc. (10086428)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 9, 2022
- Registered through
- 2026
- Brand names listed
- Aloclair Oral Gel, Aloclair Oral Rinse, Aloclair Oral Spray, Canker-X Mouth Sore Gel (Aloclair Oral Gel), Canker-X Rincinol Mouth Sore Rinse (Aloclair Oral Rinse), Canker-X Rincinol Mouth Sore Spray (Aloclair Oral Spray), Kelo-cote Advanced Formula Scar Gel, ScarAway Acne Scars Silicone Gel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Elastomer, Silicone, For Scar Management | MDA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Oral Wound Dressing | OLR | U | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 13, 2005 | K042722 | ALOCLAIR ORAL SPRAY | OLR | Substantially Equivalent | Sinclair Pharmaceuticals, Ltd. | accessdata.fda.gov |
| June 21, 2004 | K040950 | ALOCLAIR ORAL GEL | OLR | Substantially Equivalent | Sinclair Pharmaceuticals, Ltd. | accessdata.fda.gov |
| November 25, 2002 | K023155 | ALOCLAIR ORAL RINSE | OLR | Substantially Equivalent | Sinclair Pharmaceuticals, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 13, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.