Registered with FDA
Sklar Corporation
Malvern, PA, United States. Lists 35 dental device types with FDA across 2 registered establishments.
- Device types listed
- 35
- Brands and models
- 35
- 510(k) clearances
- 0as applicant
- Markets registered in
- 426 registrations outside the US
- Establishments
- 2United States
Registered in 4 markets
Where regulators' registries name Sklar Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Sklar Corporation | 35 device types | — | Below |
| South Korea | MFDS | Manufacturer | Sklar CorporationSklar | 23 | 2009–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SKLAR CORPORATION | 2 | 2006–2019 | Pure Global AI |
| Israel | AMAR | Manufacturer | Sklar Corporation | 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 Sklar Corporation currently lists, by FDA device type, with the brand and model names on the listing.
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 |
|---|---|---|
| Sklar CorporationFDA reg. 2431166 | Malvern, PA, United States | Repacker / relabeler |
| Sklar Corporation - WarehouseFDA reg. 3015895045 | Salisbury, MD, United States | Repacker / relabeler |
Other names on FDA records
Sklar Corporation - Warehouse
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023634). 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.