Manufacturer registered with FDA
Caribbean Custom Mold Inc
Santo Domingo, Dominican Republic. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Dominican Republic
Devices listed with FDA
What Caribbean Custom Mold Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Over the Counter Denture RelinerEBP · Class 2 | — | Maker | SONRISA/NSI | 2024 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Sonrisa | 2021 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Sonrisa | 2021 |
| Denture Preformed (Partially Prefabricated Denture)EKO · Class 2 | Denture resins & teeth | Maker | Sonrisa | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CARIBBEAN CUSTOM MOLD INCFDA reg. 3011087996 | Santo Domingo, Dominican Republic | Contract manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047366). 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.