| Primary Device ID | D746EB250 |
| NIH Device Record Key | 61b3526a-80a0-4e95-87a0-a3cb54d6497b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Therapy Wafer |
| Version Model Number | EB25 |
| Catalog Number | EB25 |
| Company DUNS | 116903307 |
| Company Name | DENTSPLY SIRONA ORTHODONTICS INC. |
| Device Count | 25 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D746EB250 [Unit of Use] |
| HIBCC | D746EB251 [Primary] |
| ECS | Pusher, Band, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-24 |
| Device Publish Date | 2021-12-16 |
| D746EB25M0 | THERAPY WAFER - SCENTED MINT 25PK |
| D746EB25G0 | THERAPY WAFER - SCENTED GRAPE 25PK |
| D746EB250 | THERAPY WAFER - SCENTED CHERRY 25PK |
| D746EB25PBG0 | THERAPY WAFER - SCENTED BUBBLE GUM 25PK |