FDA product code KZN: Scanner, Color
KZN is the FDA product code for scanner, color. It is a Class II device, regulated under 21 CFR 872.3661 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under KZN, from 2 different applicants. The average 510(k) review took 36 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Scanner, Color |
| Device class | Class II |
| Regulation | 21 CFR 872.3661 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KZN clearance
Top KZN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Corporation | 1 | 2007-11-16 |
| Sterndent Corp. | 1 | 1977-04-20 |
Most recent KZN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072643 | Olympus Corporation | CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US | 2007-11-16 | 59 |
| K770667 | Sterndent Corp. | CHROMASCAN TM | 1977-04-20 | 12 |
Recalls for KZN devices
openFDA lists no recalls for product code KZN.
Frequently asked questions
What is FDA product code KZN?
KZN is the FDA product code for scanner, color. It is a Class II device, regulated under 21 CFR 872.3661 and reviewed by the Dental panel.
What device class is KZN?
Class II, regulation 21 CFR 872.3661. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KZN?
Across 2 cleared submissions the average was 36 days from receipt to decision (median 36).
Which companies have the most KZN clearances?
Olympus Corporation (1); Sterndent Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KZN
- Run a recall and safety report across every KZN manufacturer
- Watch product code KZN 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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