Manufacturer registered with FDA
GLW, Inc.
Englewood Cliffs, NJ, United States. Lists 2 dental device types with FDA across 2 registered establishments.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 2Germany, United States
Registered in 2 markets
Where regulators' registries name GLW, Inc. 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 | GLW, Inc. | 2 device types | — | Below |
| Israel | AMAR | Manufacturer | GLW, Inc. | 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 GLW, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | — | 2023 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | — | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GLW Europe GmbHFDA reg. 3026593233 | Wurmlingen Baden-Wurttemberg, Germany | Foreign exporter |
| GLW, Inc.FDA reg. 3014967149 | Englewood Cliffs, NJ, United States | Complaint file establishment, Specification developer |
Other names on FDA records
GLW Europe GmbH
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058309). 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.