Zfx GmbH

FDA Device Registration & Listing · Dachau Bavaria, DE · Registration 3008932779

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
3008932779
FEI Number
3008932779
Entity Name
Zfx GmbH
City/State/Country
Dachau Bavaria, DE
Establishment Address
Kopernikusstr. 15, Dachau Bavaria 85221, DE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ZimVie US Corp LLC (Owner Number: 1038806)
Owner / Operator Contact Address
4555 Riverside Drive, --, Palm Beach Gardens, FL 33410, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Dental Accessories for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant SystemsDental Accessories for Spl GenTek

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2002-11-26
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-03-14

Official Correspondent

Ruth Lopez

US Agent Details

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

Related Public Records

Same Entity

ZimVie US Corp LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1000244346 ZimVie Canada Inc. Mississauga Ontario, CA
3006411780 ZimVie Spain S.L.U. Cornella de Llobregat Barcelona, ES
3009840806 ZimVie Spain S.L.U. Paterna Valencia, ES
1038806 ZimVie US Corp LLC Palm Beach Gardens, FL, US

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-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Similar Registrations

Registration Number Establishment Name Location
3017374693 STRATASYS LTD - Headquarter Rehovot Central, IL
3017896270 EXCELLENT PRECISION TECHNOLOGY (DONGGUAN) CO., LTD Dongguan Guangdong, CN
3042200066 HUB BIOTECH CO., LTD. BUCHEON-SI Gyeonggi, KR
3042852773 COVISION CO., LTD. Incheon, KR
3009847764 GMI DENTAL IMPLANTOLOGY, S.L. Lleida Lerida, ES
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008932779. Last updated year: 2026. Please use registration number 3008932779 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.