| Primary Device ID | 08806145440143 |
| NIH Device Record Key | 51bb6e2a-1e1e-4ded-bd8e-900ebada8c4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orthodontic Driver |
| Version Model Number | NLHD+ST-L |
| Company DUNS | 688355973 |
| Company Name | DENTOS 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 | true |
| Expiration Date | true |
| 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 | 08806145440143 [Primary] |
| ECT | Driver, Band, Orthodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
[08806145440143]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-12 |
| Device Publish Date | 2025-05-02 |
| 08806145435040 | LHD-OB-L |
| 08806145435033 | LHD-OB-S |
| 08806145435026 | LHD-B-TG |
| 08806145484086 | NLHD-S |
| 08806145440174 | NLHD-S+ST-S |
| 08806145440167 | NLHD-S+ST-L |
| 08806145440150 | NLHD+ST-S |
| 08806145440143 | NLHD+ST-L |
| 08806145440136 | LHD-B+DT-S |
| 08806145440129 | LHD-B+DT-L |