Data / Medical devices / Israel / Silmet Ltd.
Silmet Ltd.: FDA-registered device maker in OR YEHUDA Tel Aviv, Israel, 4 510(k) clearances
Silmet Ltd. is registered with the FDA (registration 8030067) in OR YEHUDA Tel Aviv, Israel. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 8, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8030067
- FEI number
- 4108
- Address
- 12 Hasadna, OR YEHUDA Tel Aviv, Israel, 6022011
- Owner or operator
- SILMET LTD. (8030067)
- Roles
- Manufacturer
- First device listed
- November 6, 1980
- Registered through
- 2026
- Brand names listed
- 37% Etching Gel, 8G Universal Adhesive, Alloy regular, Amalgam dental alloy, Avalloy, DEXITER DISPERSED AMALGAM, DEXITER SPHERICAL AMALGAM, GIC Filling and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Alloy, Amalgam | EJJ | 2 | Manufacturer | accessdata.fda.gov |
| Capsule, Dental, Amalgam | DZS | 1 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2011 | K110403 | PROLINK ADHESIVES (PROLINK, PROLINK SE) | KLE | Substantially Equivalent | Silmet , Ltd. | accessdata.fda.gov |
| February 2, 2011 | K103190 | PROFIL COMPOSITES (PROFIL, PROFIL FLOW) | EBF | Substantially Equivalent | Silmet , Ltd. | accessdata.fda.gov |
| September 29, 2010 | K101869 | PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) | EMA | Substantially Equivalent | Silmet , Ltd. | accessdata.fda.gov |
| November 15, 1976 | K760980 | DENTAL ALLOY | EJJ | Substantially Equivalent | Adp Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Agent, Tooth Bonding, Resin
- All makers of Cement, Dental
- All makers of Alloy, Amalgam
- All makers of Material, Tooth Shade, Resin
- All makers of Capsule, Dental, Amalgam
- All makers of Zinc Oxide Eugenol
Updated September 8, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.