Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015383403

FEI Number

3015383403

Entity Name

ALPHA DENT IMPLANTS GMBH

City/State/Country

Pforzheim Baden-Wurttemberg, DE

Establishment Address

Hanauer strasse 1-5, Pforzheim Baden-Wurttemberg 75181, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Alpha Dent Implants GmbH (Owner Number: 10086730)

Owner / Operator Contact Address

Hanauer strasse 1-5, Pforzheim, DE-NOTA 75181, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240435

PMA Number

N/A

All Registered Proprietary Names

Scan Abutment:ATN9-Ti ; ATN9-P; ATN9 ; ATN-Ti ; AT-MU; Digital Analog: D-ANK3;D-ANAEM IAB +3.3x8 Implant Active Bio Plus 0 3.3 L 8 ISPA 5.5x11.5 Implant Superior Active 0 5.5 L 11.5 HCWK 3/7 Wide Healing CAP 0 5.5 L 7.5 ISPA 6x10 IAB +6x10 Implant Active Bio Plus 0 6 L 10 ISPA 4.5x8 Implant Superior Active 0 4.5 L 8 Wide Healing CAP 0 8 L 3.5 ISPA 4x13 Implant Superior Active 0 4 L 13 HCAEM- W Healing Cap wide for Angular Multi-Unit 17°/30° IAB 5x11.5 Implant Active Bio Plus 0 5 L 11.5 Wide Healing CAP 0 6.5 L 7 HCWK 8/4 Wide Healing CAP 0 8 L 4.5 mplant Active, Active Plus Implants, Implant Active +, Implant Classic, INTEGRAL Implants, Wide Healing CAP 0 6.5 L 3.5 ISPA 4x10 Implant Superior Active 0 4 L 10 HCWK 6.5/7 Wide Healing CAP 0 6.5 L 7 Wide.Healing CAP 0 6.5.L-7 Wide.Healing CAP 0 8.L-4.5 IAB +4.2x16 Implant Active Bio Plus 0 4.2 L 16 ISPA 3.5x11.5 Implant Superior Active 0 3.5 L 11.5 IAB+ 5x13 Implant Active Bio Plus 0 5 L 13 Implant Active Bio Plus 0 3.75 L 8 Wide Healing CAP 0 6.5 L 4.5 ISPA 4.5x16 Implant Superior Active 0 4.5 L 16 HCWK 8/3 Wide Healing CAP 0 8 L 3.5 IAB +6x13 Implant Active Bio Plus 0 6 L 13 Implant Active Bio Plus 0 Implant Active Bio Plus Wide Healing CAP 0 5.5 L 7.5 ISPA 4x16 Implant Superior Active 0 4 L 16 IAB +3.75x13 Implant Active Bio Plus 0 3.75 L 13 Wide Healing CAP 0 8 L 4.5 ISPA 5.5x13 Implant Superior Active 0 5.5 L 13 IAB +5x10 Implant Active Bio Plus 0 5 L 10 ISPA 6x8 Implant Superior Active 0 6 L 8 HCWK 6.5/4 Wide Healing CAP 0 6.5 L 4.5 IAB +4.2x10 Implant Active Bio Plus 0 4.2 L 10 4.5 L 13 Implant Superior Active 0 4.5 L 13 ISPA 5x11.5 Implant Superior Active 0 5 L 11.5 IAB +3.3x13 Implant Active Bio Plus 0 3.3 L 13 Implant Superior Active 0 5.5 L 8 IAB +4.2x11.5 Implant Active Bio Plus 0 4.2 L 11.5 Wide Healing CAP 0 6.5 L 5.5 IAB +3.3x11.5 Implant Active Bio Plus 0 3.3 L 11.5 HCAEM Healing Cap for Angular Multi-Unit 17°/30° ISPA 5x16 Implant Superior Active 0 5 L 16 Implant Active Konus, Implant Classic Konus, Implant Active Bio, PROSTHETIC COMPONENTS TAK 3/004 Titanium Abutment Konus 3.4 mm ISPA 6x11.5 Implant Superior Active 0 6 L 11.5 IAB +4.2x13 Implant Active Bio Plus 0 4.2 L 13 Titanium Abutment Konus 3 4 mm HCWK 6.5/5 Wide Healing CAP 0 6.5 L 4.5 Sigma Implants IAB +6x8 Implant Active Bio Plus 0 6 L 8 ISPA 3.5x10 Implant Superior Active 0 3.5 L 10 HCWK 6.5/3 Wide Healing CAP 0 6.5 L 3.5 IAB +5x8 Implant Active Bio Plus 0 5 L 8 ISPA 3.5x13 Implant Superior Active 0 3.5 L 13 TAK 3/004 Titanium Abutment Konus 3 4 mm IAB +3.3x10 Implant Active Bio Plus 0 3.3 L 10 IAB +3.75x16 Implant Active Bio Plus 0 3.75 L 16 Wide.Healing CAP 0 6.5.L-5.5 IAB +6x11.5 Implant Active Bio Plus 0 6 L 11.5 ISPA 3.5x8 Implant Superior Active 0 3.5 L 8 dental implants "Implant Active Bio_" IAB +4.2x8 Implant Active Bio Plus 0 4.2 L 8 ISPA 5.5x10 Implant Superior Active 0 5.5 L 10 ISPA 4.5x10 Implant Superior Active 0 4.5 L 10 Wide.Healing CAP 0 8.L-3.5 ISPA 5x13 Implant Superior Active 0 5 L 13 IAB +3.75x10 Implant Active Bio Plus 0 3.75 L 10 IAB +3.75x11.5 Implant Active Bio Plus 0 3.75 L 11.5 dental Implant " Implant Classic_" ISPA 6x13 Implant Superior Active 0 6 L 13 Prosthetic Components Sigma Implants HCAEK Healing Cap for Aesthetic Abutment Konus ISPA 3.5x16 Implant Superior Active 0 3.5 L 16 Implant Superior Active 0 6 L 10 HCAEM Healing Cap wide for Angular Multi-Unit 17°/30° ISPA 4.5x11.5 Implant Superior Active 0 4.5 L 11.5 ISPA 4x11.5 Implant Superior Active 0 4 L 11.5 ISPA 5x10 Implant Superior Active 0 5 L 10 ISPA 4x8 Implant Superior Active 0 4 L 8 ISPA 5x8 Implant Superior Active 0 5 L 8 DENTAL IMPLANT SUPERIOR ACTIVE-ISPA AND ACTIVE BIO PLUS -IABP

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	2023-09-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-12-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-12-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-04-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-04-29

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Alpha Dent Implants 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
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

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 3015383403. Last updated year: 2026. Please use registration number 3015383403 when referencing this establishment in official correspondence.