FDA Product Code PEM: Dental Barriers And Sleeves
Intended To Serve As A Disposable Barrier For Dental Instruments To Reduce The Risk Of Cross Contamination Between Dental Patients.
Leading manufacturers include Fomed Industries, Inc., Minitube AB and Premium Plus (Dongguan) Limited.
FDA 510(k) Cleared Dental Barriers And Sleeves Devices (Product Code PEM)
About Product Code PEM - Regulatory Context
510(k) Submission Activity
15 total 510(k) submissions under product code PEM since 2014, with 15 receiving FDA clearance (average review time: 146 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PEM have taken an average of 81 days to reach a decision - down from 162 days historically, suggesting improved FDA processing for this classification.
PEM devices are reviewed by the Dental panel. Browse all Dental devices →