| Primary Device ID | 00192029027301 |
| NIH Device Record Key | bd3d8e14-95f0-4696-9465-62c0561f504a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | First Molar Single Convertible Micro6 |
| Version Model Number | 391-984 |
| Company DUNS | 005432299 |
| Company Name | TP ORTHODONTICS 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com | |
| Phone | +1(800)348-8856 |
| nicholas.smith@tportho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192029027301 [Primary] |
| DZD | TUBE, 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 | 2024-11-21 |
| Device Publish Date | 2024-11-13 |
| 00192029027295 | UR 1st Molars Torque -10, Tip 0, Distal Offset 4 |
| 00192029027288 | UL 1st Molars Torque -10, Tip 0, Distal Offset 4 |
| 00192029027318 | UR 1st Molars Torque -10, Tip 0, Distal Offset 4 0.56 mm x 0.71 mm (.022" x .028") 4.0mm |
| 00192029027301 | UL 1st Molars Torque -10, Tip 0, Distal Offset 4 0.56 mm x 0.71 mm (.022" x .028") 4.0mm |