FDA product code KCS: Pantograph
KCS is the FDA product code for pantograph. It is a Class I device, regulated under 21 CFR 872.3730 and reviewed by the Dental panel. Devices under KCS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Pantograph |
| Device class | Class I |
| Regulation | 21 CFR 872.3730 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KCS devices
openFDA lists no recalls for product code KCS.
Frequently asked questions
What is FDA product code KCS?
KCS is the FDA product code for pantograph. It is a Class I device, regulated under 21 CFR 872.3730 and reviewed by the Dental panel.
What device class is KCS?
Class I, regulation 21 CFR 872.3730. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KCS
- Run a recall and safety report across every KCS manufacturer
- Watch product code KCS 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.