Registered with FDA
Klarity Medical Products
Heath, OH, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 69 registrations outside the US
- Establishments
- 1United States
Registered in 6 markets
Where regulators' registries name Klarity Medical Products 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 | Klarity Medical Products | 2 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Klarity Medical Products, LLC | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KLARITY MEDICAL PRODUCTS | 2 | 2012–2021 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | KLARITY MEDICAL PRODUCTS, LLC | 1 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Klarity Medical Products | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | KLARITY MEDICAL PRODUCTS | 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 Klarity Medical Products currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2018 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2019 |
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
Klarity Medical Products 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: Danville Materials, LLC (1), Dentsply Intl., Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 Feb 2011 | K102753 | TURBO TEMP 3 | Danville Materials, LLC | EBG Resin Temporary Crown and Bridge |
| 31 Aug 1978 | K781151 | REPROSIL | Dentsply Intl., Inc. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| KLARITY MEDICAL PRODUCTS, LLCFDA reg. 1530561 | Heath, OH, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9031393). 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.