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510(k) K250735

Dental Barrier and Sleeves by Fomed Industries, Inc. — Product Code PEM

K250735 is an FDA 510(k) premarket notification submitted by Fomed Industries, Inc. for the device "Dental Barrier and Sleeves". The FDA issued a decision of Substantially Equivalent on June 10, 2025. The device falls under product code PEM (Dental Barriers And Sleeves), a Class II device regulated under 21 CFR 878.4370. Fomed Industries, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2025
Date Received
March 11, 2025
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 Fomed Industries, Inc.

  • K220512 — Disposable Surgical Face Mask (M01, M02) (April 25, 2022)

Other clearances for product code PEM

  • 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)
  • K190949 — ScanX Barrier Envelopes (July 26, 2019)
  • K183263 — UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope (June 14, 2019)

FDA data resources