Data / Medical devices / Capsule, Dental, Amalgam
Capsule, Dental, Amalgam (DZS): 11 FDA-registered makers in 6 countries
11 establishments in 6 countries are registered with the FDA to make Capsule, Dental, Amalgam (product code DZS, Class 1, 21 CFR 872.3110). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on September 14, 1982, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DZS
- Device class
- 1
- Regulation
- 872.3110
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Pakistan | 3 |
| China | 2 |
| Australia | 1 |
| Israel | 1 |
| Italy | 1 |
Makers of Capsule, Dental, 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 |
|---|---|---|---|---|---|---|---|---|
| Debo Medical Technology (shijiazhuang) Co., Ltd. | Shijiazhuang Hebei, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| J & J Instruments, LLC | Northbrook, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Pomona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcave Private Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sdi Ltd. | BAYSWATER Victoria, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Signor Seven International | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silmet Ltd. | OR YEHUDA Tel Aviv, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tribest Dental Products Co Ltd | Yangzhong Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volgo Care International (private) Limited | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| World Work SRL | MONTEBELLO VICENTINO Vicenza, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 14, 1982. 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.