| Primary Device ID | 00860008859556 |
| NIH Device Record Key | 96014182-8a9c-4f9d-9363-d1fad559bb40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ori |
| Version Model Number | Ori 3 Tip |
| Catalog Number | 10012 |
| Company DUNS | 118731511 |
| Company Name | Ori Inc |
| 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 | false |
| 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 | 801-367-2189 |
| support@oriscanning.com | |
| Phone | 801-367-2189 |
| support@oriscanning.com | |
| Phone | 801-367-2189 |
| support@oriscanning.com | |
| Phone | 801-367-2189 |
| support@oriscanning.com | |
| Phone | 801-367-2189 |
| support@oriscanning.com | |
| Phone | 801-367-2189 |
| support@oriscanning.com | |
| Phone | 801-367-2189 |
| support@oriscanning.com | |
| Phone | 801-367-2189 |
| support@oriscanning.com | |
| Phone | 801-367-2189 |
| support@oriscanning.com | |
| Phone | 801-367-2189 |
| support@oriscanning.com | |
| Phone | 801-367-2189 |
| support@oriscanning.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860008859556 [Primary] |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860008859556]
Moist Heat or Steam Sterilization
[00860008859556]
Moist Heat or Steam Sterilization
[00860008859556]
Moist Heat or Steam Sterilization
[00860008859556]
Moist Heat or Steam Sterilization
[00860008859556]
Moist Heat or Steam Sterilization
[00860008859556]
Moist Heat or Steam Sterilization
[00860008859556]
Moist Heat or Steam Sterilization
[00860008859556]
Moist Heat or Steam Sterilization
[00860008859556]
Moist Heat or Steam Sterilization
[00860008859556]
Moist Heat or Steam Sterilization
[00860008859556]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-02 |
| Device Publish Date | 2026-01-23 |
| 00860008859501 | Intraoral Optical Scanning System |
| 00860008859532 | Intraoral Optical Scanner |
| 00860008859525 | Intraoral Optical Scanning Tip |
| 00860008859518 | Intraoral Optical Scanning System |
| 00860008859563 | Intraoral Optical Scanner |
| 00860008859549 | Intraoral Optical Scanning System |
| 00860008859556 | Ori 3 Replacement Tips (3-Pack) |