| Primary Device ID | 00856379007023 |
| NIH Device Record Key | 8bc613cb-9b70-49c5-8dc0-a00502cfa3fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SureSmile aligner |
| Version Model Number | 1000 |
| Company DUNS | 053101262 |
| Company Name | ORAMETRIX, 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 | false |
| Lot Batch | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856379007023 [Primary] |
| NXC | Aligner, Sequential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-11 |
| Device Publish Date | 2018-09-10 |
| 00856379007283 - Motto | 2023-03-16 Motto Aligner |
| 00856379007290 - Motto | 2023-03-16 Motto Attachment Template |
| 00856379007306 - Motto | 2023-03-16 Motto Retainer |
| 00856379007122 - SureSmile® | 2022-05-17 Arch wire 16round CUNITI-NITI |
| 00856379007139 - SureSmile® | 2022-05-17 Arch wire 16x22 CUNITI-NITI |
| 00856379007146 - SureSmile® | 2022-05-17 Arch wire 17x25 CUNITI-NITI |
| 00856379007153 - SureSmile® | 2022-05-17 Arch wire 19x25 CUNITI-NITI |
| 00856379007160 - SureSmile® | 2022-05-17 Arch wire 17x25 ELGILOY |