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510(k) K201604

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

K201604 is an FDA 510(k) premarket notification submitted by Plasdent Corporation for the device "Plasdent Disposable Barrier Sleeves and Barrier Film". The FDA issued a decision of Substantially Equivalent on December 23, 2020. The device falls under product code PEM (Dental Barriers And Sleeves), a Class II device regulated under 21 CFR 878.4370.

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.

Other clearances for product code PEM

  • K250735 — Dental Barrier and Sleeves (June 10, 2025)
  • K250606 — Dental Barrier and Sleeves (May 29, 2025)
  • K242435 — Dental Barrier and Sleeves (October 18, 2024)
  • K233918 — Dental Barrier and Sleeves (May 9, 2024)
  • K220662 — Disposable Barrier Sleeves (May 11, 2022)
  • K211026 — Minitube Dentasleeve Protective Barrier Sleeves (August 3, 2021)
  • K191448 — Barrier Sleeves (October 8, 2019)
  • K190484 — BH Medical Dental Barrier Sleeves and Barrier Film (September 10, 2019)
  • K190949 — ScanX Barrier Envelopes (July 26, 2019)
  • K183263 — UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope (June 14, 2019)

FDA data resources