Data / Medical devices / United States / Perma Laboratories
Perma Laboratories: FDA-registered device maker in Hinckley, OH, United States, 1 510(k) clearance
Perma Laboratories is registered with the FDA (registration 1528710) in Hinckley, OH, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1528710
- FEI number
- 1000136230
- Address
- 120 Wakefield Run Blvd, Hinckley, OH, United States, 44233
- Owner or operator
- PERMA LABORATORIES (9006672)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- November 5, 2007
- Registered through
- 2026
- Brand names listed
- Fizz-It Denture Cleaner, P.E.R.K., Perma Soft Denture Reliner, ProSoft Denture Reliner
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleanser, Denture, Over The Counter | EFT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Denture Repair Kit | EBO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Reliner, Denture, Over The Counter | EBP | 2 | 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 |
|---|---|---|---|---|---|---|
| June 6, 2012 | K121318 | PROSOFT | EBP | Substantially Equivalent | Perma Laboratories | accessdata.fda.gov |
Compare with other makers
- All makers of Denture Repair Kit
- All makers of Reliner, Denture, Over The Counter
- All makers of Cleanser, Denture, Over The Counter
Updated June 6, 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.