Data / Medical devices / Dental Barriers And Sleeves

Dental Barriers And Sleeves (PEM): 25 FDA-registered makers in 6 countries

25 establishments in 6 countries are registered with the FDA to make Dental Barriers And Sleeves (product code PEM, Class 2, 21 CFR 878.4370). 22 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on September 17, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

PEM

Device class

2

Regulation

878.4370

Medical specialty

General, Plastic Surgery

Makers by country

Makers of Dental Barriers And Sleeves

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated September 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.