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510(k) K220662

Disposable Barrier Sleeves by Premium Plus (Dongguan) Limited — Product Code PEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2022
Date Received
March 7, 2022
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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  • K211026 — Minitube Dentasleeve Protective Barrier Sleeves (August 3, 2021)
  • K201604 — Plasdent Disposable Barrier Sleeves and Barrier Film (December 23, 2020)
  • K191448 — Barrier Sleeves (October 8, 2019)
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  • K190949 — ScanX Barrier Envelopes (July 26, 2019)
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