Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018501314

FEI Number

3018501314

Entity Name

IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL)

City/State/Country

Mulgrave Victoria, AU

Establishment Address

759 - 767 Springvale Road, Mulgrave Victoria 3170, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Osteon Medical (Owner Number: 10081414)

Owner / Operator Contact Address

759 - 767 Springvale Road, Mulgrave, AU-VIC 3170, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Osteon Prosthesis Osteon Prosthesis Osteon Prosthesis Osteon Scan Gauge Kit Osteon Prosthesis DESS Dental Smart Solutions DESS Dental Smart Solutions Osteon Prosthesis DESS Dental Smart Solutions Osteon Prosthesis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2022-10-12
NSM	Restoration, Resin	Unknown	Class N	N/A	2022-10-12
NSL	Dentures, Full	Unknown	Class N	N/A	2022-10-12
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2021-04-12
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2022-10-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-07-05
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-01-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-02-10
NSK	Dentures, Partial	Unknown	Class N	N/A	2022-10-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-02-10
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2022-10-12

Official Correspondent

Farah Rahman

US Agent Details

Farah Rahman Business: Implant Solutions Pty Ltd (Trading as Osteon Medical) Email: farah.rahman@osteonmedical.com Phone: (866) 9029272

Related Public Records

Same Entity

Osteon Medical

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023878501	IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL)	Irvine, CA, US

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-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 3018501314. Last updated year: 2026. Please use registration number 3018501314 when referencing this establishment in official correspondence.