| Primary Device ID | 08800049279670 |
| NIH Device Record Key | af465251-7d74-470b-851a-cdfbc2676a0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SM INTERNAL/EXTERNAL IMPLANT SYSTEMS |
| Version Model Number | ITN 35412 |
| Catalog Number | ITN 35412 |
| Company DUNS | 631085206 |
| Company Name | DIO Corporation |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Phone | 213-365-2875 |
| usahq@dioimplantusa.com | |
| Phone | 213-365-2875 |
| usahq@dioimplantusa.com | |
| Phone | 213-365-2875 |
| usahq@dioimplantusa.com | |
| Phone | 213-365-2875 |
| usahq@dioimplantusa.com | |
| Phone | 213-365-2875 |
| usahq@dioimplantusa.com | |
| Phone | 213-365-2875 |
| usahq@dioimplantusa.com | |
| Phone | 213-365-2875 |
| usahq@dioimplantusa.com | |
| Phone | 213-365-2875 |
| usahq@dioimplantusa.com | |
| Phone | 213-365-2875 |
| usahq@dioimplantusa.com | |
| Phone | 213-365-2875 |
| usahq@dioimplantusa.com | |
| Phone | 213-365-2875 |
| usahq@dioimplantusa.com | |
| Phone | 213-365-2875 |
| usahq@dioimplantusa.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800049279670 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800049279670]
Moist Heat or Steam Sterilization
[08800049279670]
Moist Heat or Steam Sterilization
[08800049279670]
Moist Heat or Steam Sterilization
[08800049279670]
Moist Heat or Steam Sterilization
[08800049279670]
Moist Heat or Steam Sterilization
[08800049279670]
Moist Heat or Steam Sterilization
[08800049279670]
Moist Heat or Steam Sterilization
[08800049279670]
Moist Heat or Steam Sterilization
[08800049279670]
Moist Heat or Steam Sterilization
[08800049279670]
Moist Heat or Steam Sterilization
[08800049279670]
Moist Heat or Steam Sterilization
[08800049279670]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-09 |
| Device Publish Date | 2022-03-01 |
| 08806195929612 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929605 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929599 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929421 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929780 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929773 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929766 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929759 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929742 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929735 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929728 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929711 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929698 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929667 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929643 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929636 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929629 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929582 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929575 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929568 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929551 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929544 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929537 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929520 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929513 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929506 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929490 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929483 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929476 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929469 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929452 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929445 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929438 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929414 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929407 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929391 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929384 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929377 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929360 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929353 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929346 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929339 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929308 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929292 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929285 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929186 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929179 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929162 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929155 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |
| 08806195929148 | SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. T |