Elos Accurate® Hybrid Base?
Elos Medtech Pinol A/S
ELOS MEDTECH PINOL A/S
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007689689 | 3007689689 | ELOS MEDTECH PINOL A/S | 1 | N | 2026-01-01 | Engvej 33 Goerloese Hovedstaden DK DK3330 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 102756 | 1114754142 | K251497 | Elos Accurate Hybrid Base | NHA | 2025-10-16 |
| 102756 | 2038746556 | K242025 | Elos Accurate® Hybrid Base™ | NHA | 2024-12-10 |
| 102756 | 1618248999 | K241722 | Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment | NHA | 2024-09-13 |
| 102756 | 1066015739 | K231307 | Elos Accurate Customized Abutment | NHA | 2023-12-21 |
| 102756 | 1797751884 | K230317 | Elos Accurate Hybrid Base | NHA | 2023-09-01 |
| 102756 | 1001662827 | K222044 | Elos Accurate Customized Abutment | NHA | 2022-11-30 |
| 102756 | 1745026051 | K201860 | Elos Accurate Hybrid Base | NHA | 2021-02-19 |
| 102756 | 1039135977 | K192457 | Elos Accurate Customized Abutment | NHA | 2020-01-02 |
| 102756 | 1924097737 | K191919 | Elos Accurate Hybrid Base | NHA | 2020-02-10 |
| 102756 | 1382092082 | K191890 | Elos Accurate Customized Abutment | NHA | 2020-02-06 |
| 102756 | 1816305587 | K190299 | Elos Accurate® Customized Abutment | NHA | 2019-06-26 |
| 102756 | 1066756643 | K171799 | Elos Accurate Customized Abutment, Elos Prosthetic Screw | NHA | 2018-01-15 |
| 102756 | 1173367751 | ||||
| 102756 | 1187534712 | ||||
| 102756 | 1190073739 | ||||
| 102756 | 1354751852 | ||||
| 102756 | 1357259745 | ||||
| 102756 | 1384344093 | ||||
| 102756 | 1402551483 | ||||
| 102756 | 1484603059 | ||||
| 102756 | 1490390873 | ||||
| 102756 | 1517676784 | ||||
| 102756 | 1546948220 | ||||
| 102756 | 1564957292 | ||||
| 102756 | 1637691426 | ||||
| 102756 | 1678082815 | ||||
| 102756 | 1791587667 | ||||
| 102756 | 1839437309 | ||||
| 102756 | 1851506144 | ||||
| 102756 | 2055000064 | ||||
| 102756 | 2060512829 | ||||
| 102756 | 2061950932 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NHA | 12 | 2025-10-16 |
PMN#
Elos Accurate® Hybrid Base?; Elos Accurate® Customized Abutment
Elos Medtech Pinol A/S
Elos Accurate Customized Abutment
Elos Medtech Pinol A/S
Elos Accurate Hybrid Base
Elos Medtech Pinol A/S
Elos Accurate Customized Abutment
Elos Medtech Pinol A/S
Elos Accurate Hybrid Base
Elos Medtech Pinol A/S
Elos Accurate Hybrid Base
Elos Medtech Pinol A/S
Elos Accurate Customized Abutment
Elos Medtech Pinol A/S
Elos Accurate Customized Abutment
Elos Medtech Pinol A/S
Elos Accurate® Customized Abutment
Elos Medtech Pinol A/S
Elos Accurate Customized Abutment, Elos Prosthetic Screw
Elos Medtech Pinol A/S
GUDID#
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2026-03-06
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2023-06-19
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2023-06-19
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2023-06-19
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2023-06-19
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2023-06-19
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2023-06-19
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-04
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-04
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-04
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-16
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-16
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-04
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-04
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-04
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-04
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-04
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-04
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-04
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-01-04
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-09-20
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-04-17
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-04-17
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-04-17
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-04-17
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-02-08
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-02-08
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-02-08
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-02-08
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-02-08
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-09-20
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-09-20
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-02-08
Elos Accurate Pre-Milled Blank - The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
2024-02-08
Torque Wrench - The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium and stainless steel. The Elos Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Elos Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Elos Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels.
2021-03-23
NV.C, NP, TiBase, 1mm, Crown - The TiBase is a titanium base designed to interface with a dental implant andto support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented tothe base. The base and the superstructure form a patient-specific abutment that will support adefinitive restoration, either a single crown or a multi-unit restoration. The TiBase Engaging is intended for single-unit restorations and TiBase Nonengagingis intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the TiBase.
2025-10-28
NV.C, NP, TiBase, 3mm, Crown - The TiBase is a titanium base designed to interface with a dental implant andto support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented tothe base. The base and the superstructure form a patient-specific abutment that will support adefinitive restoration, either a single crown or a multi-unit restoration. The TiBase Engaging is intended for single-unit restorations and TiBase Nonengagingis intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the TiBase.
2025-10-28
NV.C, NP, TiBase, 1mm, Bridge - The TiBase is a titanium base designed to interface with a dental implant andto support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented tothe base. The base and the superstructure form a patient-specific abutment that will support adefinitive restoration, either a single crown or a multi-unit restoration. The TiBase Engaging is intended for single-unit restorations and TiBase Nonengagingis intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the TiBase.
2025-10-28
NV.C, NP, TiBase, 3mm, Bridge - The TiBase is a titanium base designed to interface with a dental implant andto support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented tothe base. The base and the superstructure form a patient-specific abutment that will support adefinitive restoration, either a single crown or a multi-unit restoration. The TiBase Engaging is intended for single-unit restorations and TiBase Nonengagingis intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the TiBase.
2025-10-28
NV.C, RP, TiBase, 1mm, Crown - The TiBase is a titanium base designed to interface with a dental implant andto support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented tothe base. The base and the superstructure form a patient-specific abutment that will support adefinitive restoration, either a single crown or a multi-unit restoration. The TiBase Engaging is intended for single-unit restorations and TiBase Nonengagingis intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the TiBase.
2025-10-28