FDA product code KOM: Adhesive, Denture, Acacia And Karaya With Sodium Borate

KOM is the FDA product code for adhesive, denture, acacia and karaya with sodium borate. It is a Class I device, regulated under 21 CFR 872.3400 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under KOM. The average 510(k) review took 71 days (median 71).

Classification

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

Top KOM applicants

Most recent KOM clearances

Recalls for KOM devices

openFDA lists no recalls for product code KOM.

Frequently asked questions

What is FDA product code KOM?

KOM is the FDA product code for adhesive, denture, acacia and karaya with sodium borate. It is a Class I device, regulated under 21 CFR 872.3400 and reviewed by the Dental panel.

What device class is KOM?

Class I, regulation 21 CFR 872.3400. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 71 days from receipt to decision (median 71).

Which companies have the most KOM clearances?

Stiefel Research Institute, Inc. (1).

Next steps

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

All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times