| Primary Device ID | 07908611211170 |
| NIH Device Record Key | 4f7250f2-ee48-4c31-aa1b-ed0916ee3cfc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR |
| Version Model Number | 11.21.2913 |
| Company DUNS | 898330003 |
| Company Name | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 07908611211170 [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 | 2025-04-15 |
| Device Publish Date | 2025-04-07 |
| 07908611211507 - METAL BRACKETS MAGNUM ROTH 0,022" – 100 SETS | 2025-09-05 METAL BRACKETS MAGNUM ROTH 0,022" – 100 SETS |
| 07908611210333 - ICERAM-P MBT 0.022 KIT + 1 PAIR OF ESTHETIC ARCHWIRES + 1 PEARL BLUE MODULAR | 2025-04-15 1 SET ICERAM-P MBT 0.022 1 PAIR OF ESTHETIC ARCHWIRES 1 PEARL BLUE MODULAR |
| 07908611210340 - ICERAM-P MBT 0.022 KIT – 5 SETS + 1 FREE MIXED ORTHODONTIC MANNEQUIN | 2025-04-15 ICERAM-P MBT 0.022 5 SETS 1 FREE MIXED ORTHODONTIC MANNEQUIM |
| 07908611211163 - PREMIUM ELITE KIT ROTH 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR | 2025-04-15 PREMIUM ELITE KIT ROTH 0.022 – 1 SET 4 TUBES 1 PAIR OF ARCHEWIRE 1 MODULAR LIGATURE |
| 07908611211170 - PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR | 2025-04-15PREMIUM ELITE KIT MBT 0.022 1 SET 4 TUBES 1 PAIR OF ARCHWIRES 1 MODULAR LIGATURE |
| 07908611211170 - PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR | 2025-04-15 PREMIUM ELITE KIT MBT 0.022 1 SET 4 TUBES 1 PAIR OF ARCHWIRES 1 MODULAR LIGATURE |
| 07908611211200 - BUTTON WITH HOOK MJANSON | 2025-04-15 BUTTON WITH HOOK BONDING MJANSON |
| 07908611211217 - ORTHODONTIC POWER ARM BUTTON FOR BONDING MJANSON – DISK HOOK | 2025-04-15 ORTHODONTIC POWER ARM BUTTON FOR BONDING MJANSON – DISK HOOK |
| 07908611211224 - ORTHODONTIC POWER ARM BUTTON FOR CRIMPING MJANSON – DISK HOOK | 2025-04-15 ORTHODONTIC POWER ARM BUTTON FOR CRIMPING MJANSON – DISK HOOK |