MEDEALIS GMBH

FDA Device Registration & Listing · Abtsteinach Hesse, DE · Registration 3017064961

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
3017064961
FEI Number
3017064961
Entity Name
MEDEALIS GMBH
City/State/Country
Abtsteinach Hesse, DE
Establishment Address
Im Steinboehl 9, Abtsteinach Hesse 69518, DE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
MEDEALIS GmbH (Owner Number: 10094093)
Owner / Operator Contact Address
Im Steinboehl 9, Abtsteinach, DE-HE 69518, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

DESS Dental Smart Solutions DESS Dental Smart Solutions DESS Dental Smart Solutions DESS Dental Smart Solutions DESS Dental Smart Solutions

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 2025-11-20
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-11-21
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-11-20
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2025-11-20
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-11-21

Official Correspondent

Klaus Krueger

US Agent Details

Floyd Larson Business: PAXMED INTERNATIONAL, LLC Email: flarson@paxmed.com Phone: (858) 7921235

Related Public Records

Same Entity

MEDEALIS GmbH
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.
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.

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 3017064961. Last updated year: 2026. Please use registration number 3017064961 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.