FDA product code DZN: Instruments, Dental Hand
DZN is the FDA product code for instruments, dental hand. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 16 510(k) submissions under DZN, from 14 different applicants. The average 510(k) review took 80 days (median 41). FDA has posted 2 recalls for DZN devices.
Classification
| Field | Value |
|---|---|
| Device name | Instruments, Dental Hand |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DZN clearance
Top DZN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Corp. | 2 | 1979-05-21 |
| Den-Mat Corp. | 2 | 1978-01-03 |
| Kerrhawe SA | 1 | 2012-07-25 |
| Fly Cast Technologies, Inc. | 1 | 2007-08-31 |
| Ivoclar North America, Inc. | 1 | 1990-06-22 |
9 more applicants have DZN clearances. See the full list in Caduvo.
Most recent DZN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111465 | Kerrhawe SA | COMPOTHIXO | 2012-07-25 | 426 |
| K071858 | Fly Cast Technologies, Inc. | DENTAL MATRIX BAND | 2007-08-31 | 57 |
| K901919 | Ivoclar North America, Inc. | CONTACT MOLAR BANDS AND CONTOUR STRIPS | 1990-06-22 | 57 |
| K861581 | Centrix, Inc. | CENTRIX PCR MOLAR MATRIX FORMS (BANDS) | 1986-05-12 | 13 |
| K844324 | World Wide Outdoor Marketing | TIGER BAND | 1984-12-03 | 26 |
Recalls for DZN devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-12-22.
Frequently asked questions
What is FDA product code DZN?
DZN is the FDA product code for instruments, dental hand. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is DZN?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DZN?
Across 16 cleared submissions the average was 80 days from receipt to decision (median 41).
Which companies have the most DZN clearances?
Howmedica Corp. (2); Den-Mat Corp. (2); Kerrhawe SA (1); Fly Cast Technologies, Inc. (1); Ivoclar North America, Inc. (1).
Have DZN devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-12-22.
Next steps
- Run an FDA pathway report with predicate devices for product code DZN
- Run a recall and safety report across every DZN manufacturer
- Watch product code DZN 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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