FDA product code KZO: Ink, Arch Tracing
KZO is the FDA product code for ink, arch tracing. It is a Class I device, regulated under 21 CFR 872.3150 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under KZO, from 2 different applicants. The average 510(k) review took 36 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Ink, Arch Tracing |
| Device class | Class I |
| Regulation | 21 CFR 872.3150 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KZO clearance
Top KZO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bauer, Cheng & Associates, Inc. | 1 | 1981-05-05 |
| Dentsply Intl. | 1 | 1977-08-16 |
Most recent KZO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K810972 | Bauer, Cheng & Associates, Inc. | THE GNATHOMETER-M | 1981-05-05 | 26 |
| K771176 | Dentsply Intl. | GOTHIC ARCH TRACING | 1977-08-16 | 47 |
Recalls for KZO devices
openFDA lists no recalls for product code KZO.
Frequently asked questions
What is FDA product code KZO?
KZO is the FDA product code for ink, arch tracing. It is a Class I device, regulated under 21 CFR 872.3150 and reviewed by the Dental panel.
What device class is KZO?
Class I, regulation 21 CFR 872.3150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KZO?
Across 2 cleared submissions the average was 36 days from receipt to decision (median 36).
Which companies have the most KZO clearances?
Bauer, Cheng & Associates, Inc. (1); Dentsply Intl. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KZO
- Run a recall and safety report across every KZO manufacturer
- Watch product code KZO 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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