Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012623144

FEI Number

3012623144

Entity Name

DMG DIGITAL ENTERPRISES SE

City/State/Country

Hamburg, DE

Establishment Address

Elbgaustrasse 248, Hamburg 22547, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DMG Digital Enterprises SE (Owner Number: 10079030)

Owner / Operator Contact Address

Elbgaustrasse 248, Hamburg, DE-HH 22547, DE

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
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2020-11-16
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2020-11-16
QJJ	Indirect Bonding Tray	Dental	Class 1	872.5410	2021-03-10
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2020-11-16

Official Correspondent

Sinem Elif Bozkaya

US Agent Details

Pamela Papineau Business: Delphi Medical Device Consulting, Inc. Email: delphimdc@comcast.net Phone: (978) 7588322

Related Public Records

Same Entity

DMG Digital Enterprises SE

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

View Entity Profile →

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

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3043603319	MEDICARE TAGS LIMITED T/A MEDYTRAK	Galway, IE
3002725312	AMERICAN PORTWELL TECHNOLOGY, INC.	Fremont, CA, US
3007832484	JWP MANUFACTURING	Santa Clara, CA, US
3037966017	HEALTH DATA WORKS	Ponte Vedra Beach, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012623144. Last updated year: 2026. Please use registration number 3012623144 when referencing this establishment in official correspondence.