Data / Medical devices / Alloy, Amalgam
Alloy, Amalgam (EJJ): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make Alloy, Amalgam (product code EJJ, Class 2, 21 CFR 872.3070). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 74 510(k) clearances under this code, the latest on November 15, 2005, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EJJ
- Device class
- 2
- Regulation
- 872.3070
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Australia | 1 |
| Israel | 1 |
| Colombia | 1 |
| Italy | 1 |
Makers of Alloy, Amalgam
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Sdi Ltd. | BAYSWATER Victoria, Australia | Manufacturer | 6 | August 6, 2003 | 0 | 0 | 0 | api.fda.gov |
| DMG America LLC | Englewood, NJ, United States | Contract manufacturer, Manufacturer | 3 | May 25, 1995 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Specification developer | 3 | June 6, 1995 | 0 | 0 | 0 | api.fda.gov |
| Ivoclar Vivadent, Inc. | Amherst, NY, United States | Manufacturer | 2 | March 11, 1982 | 0 | 1 | 0 | api.fda.gov |
| Dentsply LLC | Milford, DE, United States | Manufacturer | 1 | November 16, 1981 | 0 | 0 | 0 | api.fda.gov |
| Silmet Ltd. | OR YEHUDA Tel Aviv, Israel | Manufacturer | 1 | November 15, 1976 | 0 | 0 | 0 | api.fda.gov |
| New Stetic | GUARNE Antioquia, Colombia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| World Work SRL | MONTEBELLO VICENTINO Vicenza, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 15, 2005. 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.