osteonmedical.comOsteon Precision Milled Suprastructure
Implant Solutions Pty Ltd (Aka Osteon Medical)
IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL)
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3018501314 | 3018501314 | IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL) | 1 | N | 2026-01-01 | 759 - 767 Springvale Road Mulgrave Victoria AU 3170 |
| 3023878501 | 3023878501 | IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL) | 1 | Y | 2026-01-01 | Suite 150, 175 Technology Drive Irvine CA US 92618 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| D102SCANGAUGEKIT0 | Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit. | +61392640111 | info@osteonmedical.com |
| D102SGKAA0 | Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit. | +61392640111 | info@osteonmedical.com |
| D102SGKAA20 | Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit. | +61392640111 | info@osteonmedical.com |
| D102SGKBC0 | Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit. | +61392640111 | info@osteonmedical.com |
| D102SGKBD0 | Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit. | +61392640111 | info@osteonmedical.com |
| D102SGKBE20 | Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit. | +61392640111 | info@osteonmedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 291233 | 1583624464 | K240208 | DESS Dental Smart Solutions | NHA | 2024-04-24 |
| 312621 | 1575841426 | K233083 | Osteon Precision Milled Suprastructure | NHA | 2024-03-09 |
| 291233 | 1575841426 | K233083 | Osteon Precision Milled Suprastructure | NHA | 2024-03-09 |
| 291233 | 1596035379 | K221019 | Osteon Precision Milled Suprastructure | NHA | 2022-07-05 |
| 312621 | 1596035379 | K221019 | Osteon Precision Milled Suprastructure | NHA | 2022-07-05 |
| 291233 | 1593316164 | K212676 | Osteon Precision Milled Suprastructure | NHA | 2022-03-03 |
| 312621 | 1593316164 | K212676 | Osteon Precision Milled Suprastructure | NHA | 2022-03-03 |
| 291233 | 2028949705 | K203464 | DESS Dental Smart Solutions | NHA | 2021-08-04 |
| 291233 | 1423813426 | K191986 | DESS Dental Smart Solutions | NHA | 2019-11-10 |
| 291233 | 1215072793 | K173908 | DESS Dental Smart Solutions | NHA | 2018-06-15 |
| 291233 | 1401300218 | K170588 | DESS Dental Smart Solutions | NHA | 2017-08-08 |
| 312621 | 1046214900 | ||||
| 291233 | 1046214900 | ||||
| 291233 | 1216723351 | ||||
| 312621 | 1216723351 | ||||
| 312621 | 1231759652 | ||||
| 291233 | 1231759652 | ||||
| 312621 | 1392940207 | ||||
| 291233 | 1392940207 | ||||
| 312621 | 1924637512 | ||||
| 291233 | 1924637512 | ||||
| 291233 | 2025498155 | ||||
| 291233 | 2070560598 | ||||
| 312621 | 2070560598 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NHA | 11 | 2024-04-24 |
PMN#
Osteon Precision Milled Suprastructure
Implant Solutions Pty Ltd (Aka Osteon Medical)
Osteon Precision Milled Suprastructure
Implant Solutions PTY LTD (Osteon Medical)
GUDID#
Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit.
2022-12-19
Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit.
2022-12-19
Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit.
2022-12-19
Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit.
2024-02-05
Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit.
2024-02-05
Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit.
2023-09-11
Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit.
2022-10-24
Osteon Medical - Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit.
2022-07-26
Osteon Medical - The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
2022-07-26
Osteon Medical - The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
2023-01-19
Osteon Medical - The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
2023-01-19
Osteon Medical - The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
2023-01-19
Osteon Medical - The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
2023-01-19
Osteon Medical - The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
2022-07-26