DZD
8 FDA 510(k) clearances · Product code
95 daysmedian time to decision
312 days90th percentile
8clearances measured
FDA profile
- Official device name
- Tube, Orthodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.5410
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2013: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ORTHODONITC ELASTOMERIC SLEEVING (K943421) | Jon-Ko Products, Inc. | 1995-05-23 |
| REGENCY TUBE (K936243) | Ortho Specialties | 1994-02-02 |
| DENTAURUM STAINLESS STEEL TUBING (K935143) | Dentauraum, Inc. | 1994-01-31 |
| NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) (K911399) | Aequitron Medical, Inc. | 1991-09-19 |
| RATE INCREASE FOR IPPB/IPV (K896586) | Percussionaire Corp. | 1990-01-09 |
| ALEXOTEK LINGUAL TUBES (K834446) | Alexotek Co. | 1984-04-05 |
| LABIAL CUSPID TUBE (K834392) | Alexotek Co. | 1984-02-28 |
| ORTHODONTIC BUCCAL TUBE (K780205) | Rocky Mountain Orthodontics, Inc. | 1978-02-16 |
Track DZD automatically
Every clearance here is in the API, with alerts when new ones post.