| Primary Device ID | 00192029015605 |
| NIH Device Record Key | ba6ee80f-0fed-48c6-8dfc-5a8ddac84246 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Molar Tube |
| Version Model Number | 391-626 |
| 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 | 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192029015605 [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 | 2021-03-23 |
| Device Publish Date | 2021-03-15 |
| 00192029050538 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UL CEN Torque +12, Tip +5 |
| 00192029050545 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UR CEN Torque +12, Tip +5 |
| 00192029050552 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UL LAT Torque +8, Tip +9 |
| 00192029050569 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UR LAT Torque +8, Tip +9 |
| 00192029050576 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UL CUS Torque -4, Tip +11 |
| 00192029050583 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UR CUS Torque -4, Tip +11 |
| 00192029050590 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UP BI CCW Torque -7, Tip 0 |
| 00192029050606 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UP BI CW Torque -7, Tip 0 |