Data / Medical devices / Anchor, Preformed
Anchor, Preformed (EJX): 11 FDA-registered makers in 6 countries
11 establishments in 6 countries are registered with the FDA to make Anchor, Preformed (product code EJX, Class 1, 21 CFR 872.3130). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on January 2, 2015, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EJX
- Device class
- 1
- Regulation
- 872.3130
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| Switzerland | 3 |
| United States | 3 |
| Italy | 2 |
| China | 1 |
| Pakistan | 1 |
| Israel | 1 |
Makers of Anchor, Preformed
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 |
|---|---|---|---|---|---|---|---|---|
| Cendres+metaux SA | Biel/Bienne Bern, Switzerland | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Nice Medical Instrument Limited Company | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Institut Straumann AG | BASEL Basel-Stadt, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nextcon International | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nobil-Metal S P A | Villafranca Dasti, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paltop Advanced Dental Solutions Ltd | Caesarea Central, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rhein 83 SRL | BOLOGNA Emilia-Romagna, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rodo Medical, Inc | Troy, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smart Denture Conversions, LLC | Apex, NC, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straumann Villeret SA | VILLERET Bern, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 2, 2015. 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.