Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009815428

FEI Number

3009815428

Entity Name

DENTONA AG

City/State/Country

Dortmund North Rhine-Westphalia, DE

Establishment Address

Feldbachacker 16, Dortmund North Rhine-Westphalia 44149, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

dentona AG (Owner Number: 10059705)

Owner / Operator Contact Address

Feldbachacker 16, Dortmund, DE-NW 44149, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

optiprint guide 405 optiprint guide 385 optiprint tray 385 optiprint tray HR optiprint clara optimill memopink optiprint durotec 405 optiprint durotec optimill memosplint optiprint splint 385 dentona flexisplint dentona vivapink optimill memosplint S dentona vivatemp optiprint interim optimill memosplnt S dentona vivatemp dentona flexisplint optimill memosplint optiprint I-B-T 385 optiprint lumina

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	2020-04-17
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2019-02-13
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2019-02-13
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2023-05-18
ELK	Teeth, Artificial, Backing And Facing	Dental	Class 1	872.3910	2020-04-17

Official Correspondent

Andreas Foerster

US Agent Details

German American Chamber of Commerce, Inc. German American Ch Email: legalservices@gaccny.com Phone: (212) 9748830

Related Public Records

Same Entity

dentona AG

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009815428. Last updated year: 2026. Please use registration number 3009815428 when referencing this establishment in official correspondence.