Data / Medical devices / United States / Factor, Ii, Inc.
Factor, Ii, Inc.: FDA-registered device maker in Lakeside, AZ, United States, 1 510(k) clearance
Factor, Ii, Inc. is registered with the FDA (registration 2023623) in Lakeside, AZ, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 28, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2023623
- Address
- 5642 White Mountain Ave, Lakeside, AZ, United States, 85929
- Owner or operator
- FACTOR, II, INC. (2023623)
- Roles
- Repackager or relabeler
- First device listed
- March 21, 1983
- Registered through
- 2026
- Brand names listed
- Daro Adhesive, Adhere Adhesive, Secure Adhesive, NFS Adhesive, MAGNABUTMENT, Magnacap, None
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Attachment, Precision, All | EGG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, External Aesthetic Restoration, Used With Adhesive | GBI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Prosthesis, Adhesive, External | GBJ | 1 | Repackager or relabeler | 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 28, 2000 | K984297 | MAGNA ABUTMENT | DZE | Substantially Equivalent | Factor, Ii, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Attachment, Precision, All
- All makers of Implant, Endosseous, Root-Form
- All makers of Prosthesis, Adhesive, External
- All makers of Material, External Aesthetic Restoration, Used With Adhesive
Updated January 28, 2000. 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.