Manufacturer registered with FDA
Glenroe, LLC
Bayside, WI, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 21992–1997
- Markets registered in
- 43 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 4 markets
Where regulators' registries name Glenroe, LLC 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 | Glenroe, LLC | 2 clearances | 1992–1997 | Below |
| Australia | TGA | Manufacturer | Glenroe LLC | 1 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Glenroe, LLC | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Glenroe, LLC | 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 Glenroe, 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 |
|---|---|---|---|---|
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Platypus Aligner Seating Chew | 2026 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Platypus | 2025 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Platypus | 2025 |
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 Glenroe, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Dec 1997 | K973495 | GLENROE GLOW IN DARK ELASTOMERIC LIGATURES | ECI Orthodontic Elastic Band |
| 27 Aug 1992 | K923124 | GLENROE GOLDEN ORTHODONTIC BRACKET | EJF Orthodontic Metal Bracket |
Some of these clearances are listed with FDA today by another company: Five Star Orthodontic Laboratory & Supply, Inc. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GLENROE, LLCFDA reg. 3040999583 | Milwaukee, WI, United States | Complaint file establishment, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094037). 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.