Data / Medical devices / United States / Akervall Technologies
Akervall Technologies: FDA-registered device maker in Saline, MI, United States, 1 510(k) clearance
Akervall Technologies is registered with the FDA (registration 3011547262) in Saline, MI, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 15, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011547262
- Address
- 1512 Woodland Dr, Saline, MI, United States, 48176
- Owner or operator
- Akervall Technologies Inc. (10048970)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 26, 2015
- Registered through
- 2026
- Brand names listed
- Intuguard, SOVA Aero, SOVA Junior, SOVA MAX, SOVA Night Guard
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleanser, Denture, Over The Counter | EFT | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 15, 2012 | K121272 | PROTECH DENT | OBR | Substantially Equivalent | Akervall Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Splint, Hand, And Components
- All makers of Mouthguard, Over-The-Counter
- All makers of Protector, Dental
- All makers of Cleanser, Denture, Over The Counter
- All makers of Tray, Impression, Preformed
Updated October 15, 2012. 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.