Product code DZD
- Device name
- Tube, Orthodontic
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.5410
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K943421 | ORTHODONITC ELASTOMERIC SLEEVING | Jon-Ko Products, Inc. | 1995-05-23 |
| K936243 | REGENCY TUBE | Ortho Specialties | 1994-02-02 |
| K935143 | DENTAURUM STAINLESS STEEL TUBING | Dentauraum, Inc. | 1994-01-31 |
| K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | Aequitron Medical, Inc. | 1991-09-19 |
| K896586 | RATE INCREASE FOR IPPB/IPV | Percussionaire Corp. | 1990-01-09 |
| K834446 | ALEXOTEK LINGUAL TUBES | Alexotek Co. | 1984-04-05 |
| K834392 | LABIAL CUSPID TUBE | Alexotek Co. | 1984-02-28 |
| K780205 | ORTHODONTIC BUCCAL TUBE | Rocky Mountain Orthodontics, Inc. | 1978-02-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07908611213839 | BONDING TUBE PREMIUM ROTH 0.018 - L67R (46/47) - 10UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-01-12 |
| 07908611213587 | BONDING TUBE PREMIUM ROTH 0.018 - L67L (36/37) - 10UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-01-12 |
| 07908611213556 | BONDING TUBE PREMIUM ROTH 0.018 - U67L (26/27) - 10UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-01-12 |
| 07908611212702 | BONDING TUBE PREMIUM ROTH 0.018 - U67R (16/17) - 10UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-01-12 |
| 07908611204264 | KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + 4 TUBES | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2025-04-02 |
| 07908611204271 | KIT ADVANCED METAL BRACKETS MBT 0.022 01 SET + ARCHES + 4 TUBES | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2025-04-02 |
| 10190886052969 | AGILITY | G & H Wire Company, Inc. | 2025-03-27 |
| 10190886052952 | AGILITY | G & H Wire Company, Inc. | 2025-03-27 |
| 07908611210050 | "PROMO KIT ADVANCED MBT 0.022""" | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2024-04-16 |
| 07908611210029 | "PROMO KIT ADVANCED ROTH 0.022""" | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2024-04-16 |
| 07908611210036 | "PROMO KIT ADVANCED ROTH 0.022""" | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2024-04-16 |
| 07908611210111 | "KIT METAL BRACKETS PREMIUM ELITE ROTH 0,022""" | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2024-04-16 |
| 07908611210043 | "PROMO KIT ADVANCED MBT 0.022""" | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2024-04-16 |
| 07908611210081 | PROMO KIT ICERAM CLASS II CORRECTOR 23MM | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2024-04-16 |
| 07908611210098 | PROMO KIT ICERAM CLASS II CORRECTOR 25MM | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2024-04-16 |
| 07908611210104 | PROMO KIT ICERAM CLASS II CORRECTOR 27MM | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2024-04-16 |
| 07908611210128 | "KIT METAL BRACKETS PREMIUM ELITE MBT 0,022""" | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2024-04-16 |
| 10190886052945 | AGILITY™ | G & H Wire Company, Inc. | 2023-10-09 |
| 07895742180614 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 08033707057406 | LEONE SPA | LEONE SPA | 2021-01-14 |
| 08033707057413 | LEONE SPA | LEONE SPA | 2021-01-14 |
| 08033707057420 | LEONE SPA | LEONE SPA | 2021-01-14 |
| 08033707057437 | LEONE SPA | LEONE SPA | 2021-01-14 |
| 08033707057444 | LEONE SPA | LEONE SPA | 2021-01-14 |
| 08033707093053 | LEONE SPA | LEONE SPA | 2021-01-14 |
| 08033707093060 | LEONE SPA | LEONE SPA | 2021-01-14 |
| 08033707093077 | LEONE SPA | LEONE SPA | 2021-01-14 |
| 08033707043669 | LEONE SPA | LEONE SPA | 2021-01-13 |
| 08033707051305 | LEONE SPA | LEONE SPA | 2020-12-18 |
| 08033707002918 | LEONE SPA | LEONE SPA | 2020-05-18 |