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 |
|---|---|---|---|
| 00840456206041 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206201 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206195 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206188 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206171 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206164 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206157 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206140 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206133 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206126 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206119 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206102 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206096 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206089 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206058 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456203514 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456206034 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456205372 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456205365 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456205358 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456205341 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456205334 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456205327 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456205310 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456205303 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456205297 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456203552 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456203545 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456203538 | JMU | JMU DENTAL, INC | 2026-06-25 |
| 00840456203521 | JMU | JMU DENTAL, INC | 2026-06-25 |