FDA product code DZB: Headgear, Extraoral, Orthodontic
DZB is the FDA product code for headgear, extraoral, orthodontic. It is a Class II device, regulated under 21 CFR 872.5500 and reviewed by the Dental panel. FDA has cleared 36 510(k) submissions under DZB, from 22 different applicants. The average 510(k) review took 99 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Headgear, Extraoral, Orthodontic |
| Device class | Class II |
| Regulation | 21 CFR 872.5500 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DZB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 350 |
| 2021 | 1 | 266 |
Compare with all 510(k) review times · Search every DZB clearance
Top DZB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ortho Kinetics Corp. | 6 | 1998-09-04 |
| Northwest Orthodontics, Inc. | 5 | 1980-04-10 |
| Ormco Corp. | 4 | 1992-12-04 |
| Ortho Technology | 2 | 2005-07-22 |
| Great Lakes Orthodontics, Ltd. | 2 | 2004-10-15 |
17 more applicants have DZB clearances. See the full list in Caduvo.
Most recent DZB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202855 | Ita.O Italian Orthodontic System S.R.L. | Orthodontic Facemask | 2021-06-21 | 266 |
| K162543 | Sawbros Industries Pvt., Ltd. | Reverse Pull Adjustable Facemask | 2017-08-28 | 350 |
| K111169 | Kwang Myung Daicom, Inc. | PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF | 2011-10-03 | 160 |
| K103019 | Kj Meditech Co., Ltd. | KJ MASK | 2011-06-09 | 240 |
| K052553 | Russell Samuels Orthodontic Design | NITOM LOCKING FACEBOW | 2005-12-22 | 97 |
Recalls for DZB devices
openFDA lists no recalls for product code DZB.
Frequently asked questions
What is FDA product code DZB?
DZB is the FDA product code for headgear, extraoral, orthodontic. It is a Class II device, regulated under 21 CFR 872.5500 and reviewed by the Dental panel.
What device class is DZB?
Class II, regulation 21 CFR 872.5500. Typical premarket route: 510(k).
How long does a 510(k) take for product code DZB?
Across 36 cleared submissions the average was 99 days from receipt to decision (median 82).
Which companies have the most DZB clearances?
Ortho Kinetics Corp. (6); Northwest Orthodontics, Inc. (5); Ormco Corp. (4); Ortho Technology (2); Great Lakes Orthodontics, Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code DZB
- Run a recall and safety report across every DZB manufacturer
- Watch product code DZB 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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