CARIBBEAN CUSTOM MOLD INC

FDA Device Registration & Listing · Santo Domingo, DO · Registration 3011087996

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011087996
FEI Number
3011087996
Entity Name
CARIBBEAN CUSTOM MOLD INC
City/State/Country
Santo Domingo, DO
Establishment Address
Zona Franca Las Americas, Aut Las Americas KM.22, Santo Domingo 11606, DO
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device
Owner / Operator
Caribbean Custom Mold Inc (Owner Number: 10047366)
Owner / Operator Contact Address
Zona Franca Las Americas, Aut Las Americas KM.22, Santo Domingo, DO-32 11606, DO
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sonrisa Sonrisa SONRISA/NSI Sonrisa

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2021-08-24
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2021-08-10
EBP Reliner, Denture, Over The Counter Dental Class 2 872.3560 2024-10-23
EKO Denture Preformed (Partially Prefabricated Denture) Dental Class 2 872.3600 2022-04-12

Official Correspondent

Randolph Geronimo

US Agent Details

James Wetherell Business: Florida Custom Mold Email: jwetherell@fla-mold.com Phone: (813) 3435080

Related Public Records

Same Entity

Caribbean Custom Mold Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011087996. Last updated year: 2026. Please use registration number 3011087996 when referencing this establishment in official correspondence.
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