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510(k) K201604

Plasdent Disposable Barrier Sleeves and Barrier Film by Plasdent Corporation — Product Code PEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2020
Date Received
June 15, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dental Barriers And Sleeves
Device Class
Class II
Regulation Number
878.4370
Review Panel
DE
Submission Type

Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.

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