FDA product code EKI: Carrier, Amalgam, Operative

EKI is the FDA product code for carrier, amalgam, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under EKI, from 2 different applicants. The average 510(k) review took 44 days (median 44).

Classification

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

Top EKI applicants

Most recent EKI clearances

Recalls for EKI devices

openFDA lists no recalls for product code EKI.

Frequently asked questions

What is FDA product code EKI?

EKI is the FDA product code for carrier, amalgam, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.

What device class is EKI?

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

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

Across 2 cleared submissions the average was 44 days from receipt to decision (median 44).

Which companies have the most EKI clearances?

Buffalo Dental Mfg. Co., Inc. (1); Premier Dental Products Co. (1).

Next steps

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