Data / Medical devices / United States / Caribbean Dental Products Corp.
Caribbean Dental Products Corp.: FDA-registered device maker in Bayamon, PR, United States, 1 510(k) clearance
Caribbean Dental Products Corp. is registered with the FDA (registration 2648744) in Bayamon, PR, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 29, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2648744
- FEI number
- 3009687539
- Address
- Industrial Minillas #460 Calle D Suite #2, Bayamon, PR, United States, 00959
- Owner or operator
- CARIBBEAN DENTAL PRODUCTS CORP. (9001050)
- Roles
- Repackager or relabeler
- First device listed
- August 17, 2015
- Registered through
- 2026
- Brand names listed
- AMALGAM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Amalgam | EJJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dental Amalgam | OIV | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mercury | ELY | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 29, 2014 | K140125 | NEW STETIC DENTAL AMALGAM ALLOY | OIV | Substantially Equivalent | New Stetic | accessdata.fda.gov |
Compare with other makers
Updated April 29, 2014. 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.