Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030488649

FEI Number

3030488649

Entity Name

ORANGECAD MED GMBH

City/State/Country

Karlsruhe Baden-Wurttemberg, DE

Establishment Address

Emmy-Noether-Str. 11, Karlsruhe Baden-Wurttemberg 76131, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

OrangeCAD Med GmbH (Owner Number: 10090072)

Owner / Operator Contact Address

Emmy-Noether-Str. 11, Karlsruhe, DE-BW 76131, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OrangeCAD Med Abutments Dental Implant Accesories

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	2026-01-07
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2024-02-12

Official Correspondent

Markus Munz

US Agent Details

John Schaible Business: SCHUTZ/SDG innovations Email: john@sdginnovations.com Phone: (203) 9221484

Related Public Records

Same Entity

OrangeCAD Med 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
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3030690317	TRATE LLC	Tamarac, FL, US
3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030488649. Last updated year: 2026. Please use registration number 3030488649 when referencing this establishment in official correspondence.