Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008409772

FEI Number

3008409772

Entity Name

RODO Digital Prosthetics

City/State/Country

Troy, MI, US

Establishment Address

1010 Naughton Dr, Troy, MI 48083, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RODO Digital Prosthetics LLC (Owner Number: 10056905)

Owner / Operator Contact Address

1010 Naughton Dr, Troy, MI 48083, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DESS Dental Smart Solutions KEYSTONE-PrimaConnex Dental Implant System THOMMEN- Milling Abutment for CAD/CAM KEYSTONE ABUTMENT SYSTEM ZIMMER BIOMET THOMMEN- SPI Titanium Base CAD/CAM Abutment SURGICAL GUIDE KEYSTONE-Genesis Implant System Abutment KEYSTONE-MAX-TL Dental Implant System KEYSTONE-PrimaConnex Esthetic Contour Zi Abutments THOMMEN

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	2023-03-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-04-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-04-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-04-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-02-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-04-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-04-09
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2019-12-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-04-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-04-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-04-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-04-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-04-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RODO Digital Prosthetics LLC

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008409772. Last updated year: 2026. Please use registration number 3008409772 when referencing this establishment in official correspondence.