Registered with FDA
Caribbean Dental Products Corp.
Bayamon, PR, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Caribbean Dental Products Corp. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Amalgam AlloyEJJ · Class 2 | — | Lister | AMALGAM | 2015 |
| MercuryELY · Class 2 | — | Lister | AMALGAM | 2015 |
| Dental AmalgamOIV · Class 2 | — | Lister | AMALGAM | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Caribbean Dental Products Corp. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: New Stetic, SA (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Apr 2014 | K140125 | NEW STETIC DENTAL AMALGAM ALLOY | New Stetic, SA | OIV Dental Amalgam |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CARIBBEAN DENTAL PRODUCTS CORP.FDA reg. 2648744 | Bayamon, PR, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9001050). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.