| Primary Device ID | 08809917096210 |
| NIH Device Record Key | 580ded10-1bc2-4fc3-906d-9580f84c93c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OssBuilder System |
| Version Model Number | SMHI315USM |
| Company DUNS | 689051793 |
| Company Name | Osstem Implant Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com | |
| Phone | +1(821)012-3412 |
| chicson@osstem.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809917096210 [Primary] |
| NHA | Abutment, implant, dental, endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-13 |
| Device Publish Date | 2023-11-04 |