| Primary Device ID | 00810044842777 |
| NIH Device Record Key | e7f4df71-7924-48f7-bdc9-3fc37f3d1018 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OnePLUS Dental Implant |
| Version Model Number | OPIA-375 |
| Company DUNS | 080694564 |
| Company Name | OSSEOFUSE INTERNATIONAL, INC. |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810044842777 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810044842777]
Moist Heat or Steam Sterilization
[00810044842777]
Moist Heat or Steam Sterilization
[00810044842777]
Moist Heat or Steam Sterilization
[00810044842777]
Moist Heat or Steam Sterilization
[00810044842777]
Moist Heat or Steam Sterilization
[00810044842777]
Moist Heat or Steam Sterilization
[00810044842777]
Moist Heat or Steam Sterilization
[00810044842777]
Moist Heat or Steam Sterilization
[00810044842777]
Moist Heat or Steam Sterilization
[00810044842777]
Moist Heat or Steam Sterilization
[00810044842777]
Moist Heat or Steam Sterilization
[00810044842777]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-03 |
| Device Publish Date | 2025-11-25 |
| 00810044842906 | OPID-R-L |
| 00810044842890 | OPID-R-S |
| 00810044842883 | OPID-M-L |
| 00810044842876 | OPID-M-S |
| 00810044842869 | OFOS-2035 |
| 00810044842852 | OFLD-1833 |
| 00810044842845 | OFLD-1626 |
| 00810044842838 | OPIC-525 |
| 00810044842821 | OPIC-450 |
| 00810044842814 | OPIC-375 |
| 00810044842807 | OPIC-300 |
| 00810044842791 | OPIA-525 |
| 00810044842784 | OPIA-450 |
| 00810044842777 | OPIA-375 |
| 00810044842760 | OPIA-300 |