Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029906226

FEI Number

3029906226

Entity Name

BIOSTAR LABORATORIOS SLU

City/State/Country

madrid, ES

Establishment Address

CALLE LAGUNA DEL MARQUESADO, 19, PLANTA 2 28021 MADRID (Spain), CALLE GARZAS N 18, 28320 PINTO - MADRID (Spain), madrid 28021, ES

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BIOSTAR LABORATORIOS SLU (Owner Number: 10088731)

Owner / Operator Contact Address

CALLE LAGUNA DEL MARQUESADO, 19, PLANTA 2 28021 MADRID (Spain), CALLE GARZAS N 18, 28320 PINTO - MADRID (Spain), madrid, ES-MD 28021, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-10-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-10-06

Official Correspondent

Ana Isabel Garcia

US Agent Details

HUMBERTO E. RUIZ Business: HUMBERTO E. Email: humberto@ruizandcompany.com Phone: (561) 4437191

Related Public Records

Same Entity

BIOSTAR LABORATORIOS SLU

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

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3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
3031529635	TRATE UAB	Kaunas Kauno Apskritis, LT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029906226. Last updated year: 2026. Please use registration number 3029906226 when referencing this establishment in official correspondence.