| Primary Device ID | 00192029020517 |
| NIH Device Record Key | 6051da95-b608-48d4-ba0a-fbe10c1cf6eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Second Molar Single Tubes |
| Version Model Number | 391-633 |
| 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 | 00192029020517 [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 |
| 00192029020838 | LR 2nd Molar Torque -25, Tip 0, Distal Offset 6 |
| 00192029020821 | LL 2nd Molar Torque -25, Tip 0, Distal Offset 6 |
| 00192029020531 | LR 2nd Molar Mini Size Torque -10, Tip 0, Distal Offset 0 |
| 00192029020524 | LL 2nd Molar Mini Size Torque -10, Tip 0, Distal Offset 0 |
| 00192029020500 | UL 2nd Molar Mini Size Torque -14, Tip 0, Distal Offset 10 |
| 00192029019832 | UL 2nd Molar W/O Distal Extension Torque -14, Tip 0, Distal Offset 14 |
| 00192029019825 | UR 2nd Molar W/O Distal Extension Torque -14, Tip 0, Distal Offset 14 |
| 00192029019818 | UL 2nd Molar W/O Distal Extension Torque -10, Tip 0, Distal Offset 14 |
| 00192029019801 | UR 2nd Molar W/O Distal Extension Torque -10, Tip 0, Distal Offset 14 |
| 00192029019771 | UL 2nd Molar W/O Distal Extension Torque -10, Tip 0, Distal Offset 14 |
| 00192029019764 | UR 2nd Molar W/O Distal Extension Torque -10, Tip 0, Distal Offset 14 |
| 00192029019757 | LL 2nd Molar W/O Distal Extension Torque -30, Tip 0, Distal Offset 4 |
| 00192029019740 | LR 2nd Molar W/O Distal Extension Torque -30, Tip 0, Distal Offset 4 |
| 00192029019658 | LL 2nd Molar W/O Distal Extension Torque -25, Tip 0, Distal Offset 4 |
| 00192029019641 | LR 2nd Molar W/O Distal Extension Torque -25, Tip 0, Distal Offset 4 |
| 00192029019634 | LL 2nd Molar W/O Distal Extension Torque -25, Tip 0, Distal Offset 4 |
| 00192029019627 | LR 2nd Molar W/O Distal Extension Torque -25, Tip 0, Distal Offset 4 |
| 00192029013526 | UR 2nd Molar Torque -10, Tip 0, Distal Offset 6 |
| 00192029013519 | UL 2nd Molar Torque -10, Tip 0, Distal Offset 6 |
| 00192029013403 | LR 2nd Molar Mini Size Torque -10, Tip 0, Distal Offset 0 |
| 00192029013397 | LL 2nd Molar Mini Size Torque -10, Tip 0, Distal Offset 0 |
| 00192029013380 | UR 2nd Molar Mini Size Torque -14, Tip 0, Distal Offset 10 |
| 00192029013373 | UL 2nd Molar Mini Size Torque -14, Tip 0, Distal Offset 10 |
| 00192029020517 | UR 2nd Molar Mini Size Torque -14, Tip 0, Distal Offset 10 0.46 mm 0.64 mm (.018"x .025") 2.3 mm |