FDA product code MEF: Ring, Teething, Non-Fluid Filled

MEF is the FDA product code for ring, teething, non-fluid filled. It is a Class I device, regulated under 21 CFR 872.5550 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under MEF. The average 510(k) review took 299 days (median 299). FDA has posted 1 recall for MEF devices.

Classification

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

Top MEF applicants

Most recent MEF clearances

Recalls for MEF devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-01-06.

Frequently asked questions

What is FDA product code MEF?

MEF is the FDA product code for ring, teething, non-fluid filled. It is a Class I device, regulated under 21 CFR 872.5550 and reviewed by the Dental panel.

What device class is MEF?

Class I, regulation 21 CFR 872.5550. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 299 days from receipt to decision (median 299).

Which companies have the most MEF clearances?

Vibe 2000 (1).

Have MEF devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2014-01-06.

Next steps

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