Manufacturer registered with FDA
Myerson LLC
Chicago, IL, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 15
- 510(k) clearances
- 12023–2023
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Myerson LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | DentiveraDuraFlex CAD discPermaSoftTrusanaTrusana bondTrusana1VisiClear CAD disc | 2019 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Lister | KensonMyersonSwissident | 2009 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Lister | EMA CAD discEMA Custom KitEMA thermoforming discs, Bite pads & Buttons, Elastic Straps | 2009 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Lister | TrusanaTrusana1 | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Myerson LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 Apr 2023 | K230098 | Trusana | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: The Myerson Company Limited (1).
Also lists devices cleared under other names
Myerson LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dental Solutions, LLC (1), Cosmetic Dental Materials, Inc. (1), Frantz Design, Inc. (1), Austenal, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Jun 2016 | K160498 | Dentivera Milling Disc | Dental Solutions, LLC | EBI Rebasing Repairing Relining Denture Resin |
| 8 Feb 2007 | K063626 | DURAFLEX | Cosmetic Dental Materials, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 29 Sep 1997 | K971794 | ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE | Frantz Design, Inc. | LRK Anti-Snoring Device |
| 4 Nov 1992 | K924526 | DENTURE PLASTIC TEETH | Austenal, Inc. | ELM Teeth Plastic Denture |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MYERSON LLCFDA reg. 3003928050 | Chicago, IL, United States | Complaint file establishment, Contract manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10029226). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.