Data / Medical devices / United States / Ohlendorf Company
Ohlendorf Company: FDA-registered device maker in Affton, MO, United States, 2 510(k) clearances
Ohlendorf Company is registered with the FDA (registration 1000380364) in Affton, MO, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 19, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000380364
- Address
- 9781 Green Park Industrial Dr, Affton, MO, United States, 63123
- Owner or operator
- OHLENDORF COMPANY (9086387)
- Roles
- Manufacturer
- First device listed
- April 27, 2006
- Registered through
- 2026
- Brand names listed
- Clear Express, Clear Force, Perio Protect Tray
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Fluoride, Disposable | KMT | 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 |
|---|---|---|---|---|---|---|
| May 19, 2021 | K210540 | Ohlendorf Clear Aligner | NXC | Substantially Equivalent | Ohlendorf Appliance Laboratory | accessdata.fda.gov |
| January 23, 2004 | K031809 | PERIO PROTECT TRAY | KMT | Substantially Equivalent | Perio Protect, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 19, 2021. 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.