Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010869261

FEI Number

3010869261

Entity Name

LASAK S.R.O.

City/State/Country

Praha 9 Praha, Hlavni Mesto, CZ

Establishment Address

Ceskobrodska 1047/46, Praha 9 Praha, Hlavni Mesto 190 00, CZ

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

LASAK s.r.o. (Owner Number: 10090808)

Owner / Operator Contact Address

Ceskobrodska 1047/46, Praha 9, CZ-10 190 00, CZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GenTek

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	2024-05-16

Official Correspondent

Marie Strnadova

US Agent Details

Henrique Nomelini Muniz Business: ZimVie US Corp LLC Email: 3ipbg-Regulatoryaffairs@Zimvie.com Phone: (561) 7766700

Related Public Records

Same Entity

LASAK s.r.o.

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.

Similar Registrations

Registration Number	Establishment Name	Location
3013578168	DDS CARIBBEAN CORP	Guaynabo, PR, US
3030690317	TRATE LLC	Tamarac, FL, US
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 3010869261. Last updated year: 2026. Please use registration number 3010869261 when referencing this establishment in official correspondence.