Data / Medical devices / United States / Keller Laboratories
Keller Laboratories: FDA-registered device maker in Fenton, MO, United States, 2 510(k) clearances
Keller Laboratories is registered with the FDA (registration 3006650414) in Fenton, MO, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 16, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006650414
- Address
- 160 Larkin Williams Ind Ct, Fenton, MO, United States, 63026
- Owner or operator
- National Dentex LLC (10040830)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 12, 2012
- Registered through
- 2027
- Brand names listed
- ClearDream, EMA, NTITSS, TAP Thornton Adjustable Positioner
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mouthguard, Migraine/Tension Headache | OCO | U | 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 |
|---|---|---|---|---|---|---|
| October 16, 2014 | K133390 | NDX DORSAL APPLIANCE | LRK | Substantially Equivalent | Institute For Quality Resource Management | accessdata.fda.gov |
| June 20, 2001 | K010876 | NTI TENSION SUPPRESSION SYSTEM | OCO | Substantially Equivalent | Nti-Tss, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 16, 2014. 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.