Manufacturer registered with FDA
Silmet , Ltd.
OR YEHUDA, Israel. Lists 6 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 65
- 510(k) clearances
- 32010–2011
- Markets registered in
- 1281 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name Silmet , Ltd. 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 | Silmet , Ltd. | 3 clearances | 2010–2011 | Below |
| Canada | Health Canada | Registration holder | SILMET LTD | 23 | 2013–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SILMET LTD | 11 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SILMET LTD. | 10 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SILMET LTDSILMET LTD. | 9 | 2006–2022 | Pure Global AI |
| Philippines | FDA Philippines | Manufacturer | Silmet Ltd. | 8 | 2025–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Silmet Ltd. | 5 | 2024–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Silmet Ltd. | 4 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Silmet Ltd | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Silmet Ltd | 3 | 2021–2021 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Silmet Ltd. | 2 | 2025–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Silmet Limited | 2 | — | 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 Silmet , Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Amalgam Dental CapsuleDZS · Class 1 | — | Maker | DEXITER DISPERSED AMALGAMDEXITER SPHERICAL AMALGAMNOGAMAPROCOPPERPROSILVERSPHERODON +SPHERODON M | 1980 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Hybrid FlowableProFilProFil BulkProFil CoreProFil FlowProFil Flow LVProFil Flow SEProFil MonoProFil PosteriorProFil Seal 5 moreProFil TempProfil UniversalProVeneerProVeneer FlowUniversal Composite | 2011 |
| Amalgam AlloyEJJ · Class 2 | — | Maker | Alloy regularAmalgam dental alloyAvalloyDEXITER DISPERSED AMALGAMDEXITER SPHERICAL AMALGAMNOGAMANualloyPROCOPPERPROSILVERSPHERODON + 4 moreSPHERODON MSpherodon M EconomVentura High AlloyVentura NG | 2008 |
| Dental CementEMA · Class 2 | Dental cements | Maker | GIC FillingGIC LutingLuting cemProBaseProBase FProGlass NineProGlass OneProGlass PlusProGlass Plus CemProGlass Silver 5 moreProGlass TwoProGlass Two LCResin cementRMGI CementSA Resin Cement | 2010 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | ProZoe | 2022 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | ProEtchProLinkProLink BlockProLink CemProLink Cem PlusProLink Cem PrimerProLink EthanolProLink MProLink SEProLink Universal 3 moreProVeneer Bond37% Etching Gel8G Universal Adhesive | 2011 |
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 Silmet , Ltd. as the applicant.
Also lists devices cleared under other names
Silmet , Ltd. 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: Adp Intl., Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Nov 1976 | K760980 | DENTAL ALLOY | Adp Intl., Inc. | EJJ Amalgam Alloy |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SILMET LTD.FDA reg. 8030067 | OR YEHUDA Tel Aviv, Israel | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030067). 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.