FDA product code DZC: Wire, Orthodontic
DZC is the FDA product code for wire, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel. FDA has cleared 30 510(k) submissions under DZC, from 14 different applicants. The average 510(k) review took 116 days (median 122). FDA has posted 4 recalls for DZC devices.
Classification
| Field | Value |
|---|---|
| Device name | Wire, 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 DZC clearance
Top DZC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Highland Metals | 7 | 1994-05-18 |
| Ultimate Wireforms, Inc. | 5 | 1993-03-31 |
| Gac Intl., Inc. | 3 | 1992-11-04 |
| Dentauraum, Inc. | 2 | 1994-02-04 |
| Flexmedics | 2 | 1994-01-21 |
9 more applicants have DZC clearances. See the full list in Caduvo.
Most recent DZC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K112640 | Ormco Corp. | HYPERELASTIC WIRE | 2011-11-16 | 65 |
| K943334 | Jay H. Geller | HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT | 1994-10-05 | 85 |
| K935638 | Highland Metals | NITINOL, NITI | 1994-05-18 | 176 |
| K935140 | Dentauraum, Inc. | DENTAURUM STEEL LIGATURE WIRES | 1994-02-04 | 99 |
| K935142 | Dentauraum, Inc. | DENTAURUM WIRES | 1994-01-31 | 95 |
Recalls for DZC devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-11-04.
Frequently asked questions
What is FDA product code DZC?
DZC is the FDA product code for wire, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel.
What device class is DZC?
Class I, regulation 21 CFR 872.5410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DZC?
Across 30 cleared submissions the average was 116 days from receipt to decision (median 122).
Which companies have the most DZC clearances?
Highland Metals (7); Ultimate Wireforms, Inc. (5); Gac Intl., Inc. (3); Dentauraum, Inc. (2); Flexmedics (2).
Have DZC devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2015-11-04.
Next steps
- Run an FDA pathway report with predicate devices for product code DZC
- Run a recall and safety report across every DZC manufacturer
- Watch product code DZC 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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