FDA product code DZD: Tube, Orthodontic
DZD is the FDA product code for tube, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel. FDA has cleared 8 510(k) submissions under DZD, from 7 different applicants. The average 510(k) review took 107 days (median 86). FDA has posted 4 recalls for DZD devices.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Orthodontic |
| Device class | Class I |
| Regulation | 21 CFR 872.5410 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DZD clearance
Top DZD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alexotek Co. | 2 | 1984-04-05 |
| Jon-Ko Products, Inc. | 1 | 1995-05-23 |
| Ortho Specialties | 1 | 1994-02-02 |
| Dentauraum, Inc. | 1 | 1994-01-31 |
| Aequitron Medical, Inc. | 1 | 1991-09-19 |
2 more applicants have DZD clearances. See the full list in Caduvo.
Most recent DZD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943421 | Jon-Ko Products, Inc. | ORTHODONITC ELASTOMERIC SLEEVING | 1995-05-23 | 312 |
| K936243 | Ortho Specialties | REGENCY TUBE | 1994-02-02 | 34 |
| K935143 | Dentauraum, Inc. | DENTAURUM STAINLESS STEEL TUBING | 1994-01-31 | 95 |
| K911399 | Aequitron Medical, Inc. | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | 1991-09-19 | 174 |
| K896586 | Percussionaire Corp. | RATE INCREASE FOR IPPB/IPV | 1990-01-09 | 48 |
Recalls for DZD devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-01-17.
| Year | Recalls |
|---|---|
| 2020 | 2 |
Frequently asked questions
What is FDA product code DZD?
DZD is the FDA product code for tube, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel.
What device class is DZD?
Class I, regulation 21 CFR 872.5410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DZD?
Across 8 cleared submissions the average was 107 days from receipt to decision (median 86).
Which companies have the most DZD clearances?
Alexotek Co. (2); Jon-Ko Products, Inc. (1); Ortho Specialties (1); Dentauraum, Inc. (1); Aequitron Medical, Inc. (1).
Have DZD devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2020-01-17.
Next steps
- Run an FDA pathway report with predicate devices for product code DZD
- Run a recall and safety report across every DZD manufacturer
- Watch product code DZD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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