FDA product code MVL: Cord, Retraction

MVL is the FDA product code for cord, retraction. It is a Unclassified device, reviewed by the Dental panel. FDA has cleared 36 510(k) submissions under MVL, 5 in the last five years, from 23 different applicants. The average 510(k) review took 144 days (median 106); 184 days on average over the last three years. FDA has posted 1 recall for MVL devices, 1 initiated in the last five years.

Classification

510(k) clearances per year for MVL

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

Top MVL applicants

18 more applicants have MVL clearances. See the full list in Caduvo.

Most recent MVL clearances

Recalls for MVL devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-05-27.

Frequently asked questions

What is FDA product code MVL?

MVL is the FDA product code for cord, retraction. It is a Unclassified device, reviewed by the Dental panel.

What device class is MVL?

Unclassified. Typical premarket route: 510(k).

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

Across 36 cleared submissions the average was 144 days from receipt to decision (median 106).

Which companies have the most MVL clearances?

Kerr Corporation (5); Ultradent Products, Inc. (4); Centrix, Inc. (3); Belport Company, Inc., Gingi-Pak (2); Inter-Med/Vista Dental Products (2).

Have MVL devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2026-05-27.

Next steps

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