FDA product code KOK: Sterilizer, Endodontic Dry Heat
KOK is the FDA product code for sterilizer, endodontic dry heat. It is a Class III device, regulated under 21 CFR 872.6730 and reviewed by the Dental panel. Devices under KOK reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs on 4/21/97 per 62 FR 2902 on 1/21/97
Classification
| Field | Value |
|---|---|
| Device name | Sterilizer, Endodontic Dry Heat |
| Device class | Class III |
| Regulation | 21 CFR 872.6730 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | PMA |
Recalls for KOK devices
openFDA lists no recalls for product code KOK.
Frequently asked questions
What is FDA product code KOK?
KOK is the FDA product code for sterilizer, endodontic dry heat. It is a Class III device, regulated under 21 CFR 872.6730 and reviewed by the Dental panel.
What device class is KOK?
Class III, regulation 21 CFR 872.6730. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KOK
- Run a recall and safety report across every KOK manufacturer
- Watch product code KOK 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.