Data / Medical devices / United States / Myerson LLC
Myerson LLC: FDA-registered device maker in Chicago, IL, United States, 5 510(k) clearances
Myerson LLC is registered with the FDA (registration 3003928050) in Chicago, IL, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003928050
- Address
- 5106 N Ravenswood Ave, Chicago, IL, United States, 60640
- Owner or operator
- Myerson LLC (10029226)
- Roles
- Complaint file establishment, Contract manufacturer, Repackager or relabeler
- First device listed
- May 11, 2009
- Registered through
- 2026
- Brand names listed
- Dentivera, DuraFlex CAD disc, EMA CAD disc, EMA Custom Kit, EMA thermoforming discs, Bite pads & Buttons, Elastic Straps, Kenson, Myerson, PermaSoft and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Complaint file establishment | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Complaint file establishment | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Complaint file establishment | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Complaint file establishment, Contract 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 |
|---|---|---|---|---|---|---|
| April 13, 2023 | K230098 | Trusana | EBI | Substantially Equivalent | Myerson, LLC | accessdata.fda.gov |
| June 15, 2016 | K160498 | Dentivera Milling Disc | EBI | Substantially Equivalent | Dental Solutions, LLC | accessdata.fda.gov |
| February 8, 2007 | K063626 | DURAFLEX | EBI | Substantially Equivalent | Cosmetic Dental Materials, Inc. | accessdata.fda.gov |
| September 29, 1997 | K971794 | ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE | LRK | Substantially Equivalent | Frantz Design, Inc. | accessdata.fda.gov |
| November 4, 1992 | K924526 | DENTURE PLASTIC TEETH | ELM | Substantially Equivalent | Austenal, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Additively Manufactured, Preformed, Resin Denture Tooth
- All makers of Denture, Plastic, Teeth
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Device, Anti-Snoring
Updated April 13, 2023. 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.