Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042849555

FEI Number

3042849555

Entity Name

RESTORATIVE LAB SPA

City/State/Country

Las Condes Region Metropolitana, CL

Establishment Address

Av. Apoquindo 6410, Oficina 605, Las Condes Region Metropolitana 8320000, CL

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RESTORATIVE LAB SpA (Owner Number: 10094116)

Owner / Operator Contact Address

Av. Apoquindo 6410, Oficina 605, Las Condes, CL-RM 8320000, CL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RESTORATIVE LAB - 3D Printed Veneer RESTORATIVE LAB - 3D Printed Model RESTORATIVE LAB - 3D Printed Bridges RESTORATIVE LAB - 3D Printed Crowns RESTORATIVE LAB - 3D Printed Guides RESTORATIVE LAB - 3D Printed All on X RESTORATIVE LAB - TITANIUM ABUTMENT RESTORATIVE LAB - TITANIUM BAR RESTORATIVE LAB Porcelain Crown RESTORATIVE LAB Porcelain Dental Restorations RESTORATIVE LAB Porcelain Veneer RESTORATIVE LAB - Porcelain All on X RESTORATIVE LAB Porcelain Inlay/Onlay

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2025-12-20
EHO	Bar, Preformed	Dental	Class 1	872.3165	2025-12-20
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2025-12-20

Official Correspondent

Gabriela Mata

US Agent Details

Michael Defee Business: WRMDSV 1 LLC Email: dr.defee@themodinstitute.com Phone: (843) 8610986

Related Public Records

Same Entity

RESTORATIVE LAB SpA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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3009509745	DENT A PHARM PRODUKTIONSGESELLSCHAFT MBH	Barmstedt Schleswig-Holstein, DE
2411056	BUFFALO DENTAL MFG. CO., INC.	SYOSSET, NY, US
1417846	FRICKE DENTAL MFG. CO.	Streamwood, IL, US
3016447764	DSI DENTAL SOLUTIONS LTD	Ashdod Southern, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042849555. Last updated year: 2026. Please use registration number 3042849555 when referencing this establishment in official correspondence.