Manufacturer registered with FDA
The Myerson Company Limited
Laventille, Trinidad & Tobago. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 18
- 510(k) clearances
- 12017–2017
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Trinidad & Tobago
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name The Myerson Company Limited as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | The Myerson Company Limited | 1 clearances | 2017–2017 | Below |
| Israel | AMAR | Manufacturer | The Myerson Company Limited | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What The Myerson Company Limited 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 | DentiveraDuraCetalDuraFlexPermaSoftTrusanaTrusana BondTrusana1VisiClearZirlux | 2009 |
| Preformed ClaspEHP · Class 1 | — | Maker | DurAcetal | 2009 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | KensonMyersonSwissident | 2009 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | EMAEMA CADEMA Custom | 2015 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | 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
Also lists devices cleared under other names
The Myerson Company Limited 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: Austenal, Inc. (2), Myerson LLC (1), Dental Solutions, LLC (1), Cosmetic Dental Materials, Inc. (1), Inovativ, LLC (1), Frantz Design, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 13 Apr 2023 | K230098 | Trusana | Myerson LLC | EBI Rebasing Repairing Relining Denture Resin |
| 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 Aug 2002 | K022032 | ACETAL | Inovativ, LLC | EHP Preformed Clasp |
| 29 Sep 1997 | K971794 | ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE | Frantz Design, Inc. | LRK Anti-Snoring Device |
| 5 Jan 1994 | K933468 | MYERSON'S PERMASOFT SOFT RELINE MATERIAL | Austenal, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 4 Nov 1992 | K924526 | DENTURE PLASTIC TEETH | Austenal, Inc. | ELM Teeth Plastic Denture |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| The Myerson Company LimitedFDA reg. 8010019 | Laventille San JuanLaventille, Trinidad & Tobago | Contract manufacturer, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9049721). 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.