Data / Medical devices / United States / Integrated Solutions, Inc.
Integrated Solutions, Inc.: FDA-registered device maker in Augusta, GA, United States, 1 510(k) clearance
Integrated Solutions, Inc. is registered with the FDA (registration 3021283891) in Augusta, GA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 31, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021283891
- Address
- 4003 Enterprise Court, Augusta, GA, United States, 30907
- Owner or operator
- Integrated Solutions, Inc. (10083760)
- Roles
- Manufacturer
- First device listed
- December 16, 2021
- Registered through
- 2026
- Brand names listed
- BioLube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | 1 | Manufacturer | 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 31, 1994 | K925080 | TEK-LUBE | EFB | Substantially Equivalent | Clinical Technology Corp. | accessdata.fda.gov |
Compare with other makers
Updated January 31, 1994. 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.