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510(k) K262073

Hygienic Protective Bite Cover (2207-010-50) by Dürr Dental SE — Product Code PEM

K262073 is an FDA 510(k) premarket notification submitted by Dürr Dental SE for the device "Hygienic Protective Bite Cover (2207-010-50)". The FDA issued a decision of Substantially Equivalent on September 17, 2026. The device falls under product code PEM (Dental Barriers And Sleeves), a Class II device regulated under 21 CFR 878.4370. Dürr Dental SE has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2026
Date Received
June 22, 2026
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 by Dürr Dental SE

  • K203287 — DBSWIN, VISTAEASY (November 18, 2020)
  • K202633 — ScanX Edge (October 7, 2020)

Other clearances for product code PEM

  • K261956 — Dental Barriers and Sleeves (AB0006) (September 8, 2026)
  • 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)
  • K201604 — Plasdent Disposable Barrier Sleeves and Barrier Film (December 23, 2020)
  • K191448 — Barrier Sleeves (October 8, 2019)
  • K190484 — BH Medical Dental Barrier Sleeves and Barrier Film (September 10, 2019)

FDA data resources