| Primary Device ID | 05712821015945 |
| NIH Device Record Key | 59f5b4f3-a6a0-4c2e-91ab-a7422b33baa2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elos Accurate® Prosthetic Screwdriver 18mm |
| Version Model Number | 042.0018 |
| Catalog Number | 042.0018 |
| Company DUNS | 306155953 |
| Company Name | Elos Medtech Pinol A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05712821015945 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
[05712821015945]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-08 |
| Device Publish Date | 2025-08-31 |
| 05712821016140 - Elos Accurate® Scan Body Kit | 2025-09-11 The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding |
| 05712821015747 - Elos Accurate® Scan Body 22 | 2025-09-08 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa |
| 05712821015761 - Elos Accurate® Scan Body 22 | 2025-09-08 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa |
| 05712821015785 - Elos Accurate® Scan Body 22 | 2025-09-08 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa |
| 05712821015792 - Elos Accurate® Analog for Printed Models | 2025-09-08 The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titani |
| 05712821015808 - Elos Accurate® Analog for Printed Models | 2025-09-08 The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titani |
| 05712821015815 - Elos Accurate® Analog for Printed Models | 2025-09-08 The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titani |
| 05712821015945 - Elos Accurate® Prosthetic Screwdriver 18mm | 2025-09-08The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. The product is available in different lengths. For specific product descriptions, please refer to individual product labels. |
| 05712821015945 - Elos Accurate® Prosthetic Screwdriver 18mm | 2025-09-08 The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. The product is available in diffe |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ELOS ACCURATE 86837307 5135482 Live/Registered |
Elos Medtech AB 2015-12-02 |