FDA product code EKK: Spreader, Pulp Canal Filling Material, Endodontic

EKK is the FDA product code for spreader, pulp canal filling material, endodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under EKK. The average 510(k) review took 78 days (median 78).

Classification

Compare with all 510(k) review times · Search every EKK clearance

Top EKK applicants

Most recent EKK clearances

Recalls for EKK devices

openFDA lists no recalls for product code EKK.

Frequently asked questions

What is FDA product code EKK?

EKK is the FDA product code for spreader, pulp canal filling material, endodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.

What device class is EKK?

Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code EKK?

Across 1 cleared submissions the average was 78 days from receipt to decision (median 78).

Which companies have the most EKK clearances?

Sturgeon Engineering Co. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code EKK
• Run a recall and safety report across every EKK manufacturer
• Watch product code EKK 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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