SureSmile® Aligner ASSY-500016
GUDID 00856379007276
SureSmile Aligner (10 hours/day)
ORAMETRIX, INC.
Orthodontic progressive aligner| Primary Device ID | 00856379007276 |
| NIH Device Record Key | 2427c574-9a55-4140-9702-c557c69fa832 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SureSmile® Aligner |
| Version Model Number | 1000 |
| Catalog Number | ASSY-500016 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856379007276 [Primary] |
FDA Product Code
| NXC | Aligner, Sequential |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-09 |
| Device Publish Date | 2022-04-29 |
Devices Manufactured by ORAMETRIX, INC.
| 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 |
Trademark Results [SureSmile]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURESMILE 97058764 not registered Live/Pending |
Dentsply Sirona Orthodontics Inc. 2021-10-04 |
 SURESMILE 75818755 2724644 Live/Registered |
ORAMETRIX, INC. 1999-10-08 |
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