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 |
|---|---|---|---|
| 00197998253447 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253584 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253577 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253560 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253553 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253546 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253539 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253522 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253515 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253508 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253492 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253485 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253478 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253461 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253454 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998070198 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253430 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253423 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253416 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253409 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253393 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998253386 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998107900 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998107887 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998101694 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998101670 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998075674 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998075063 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998070211 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |
| 00197998070204 | Solventum | Solventum Orthodontics Corporation | 2026-10-24 |