Home / 510(k) Clearances / K261956

510(k) K261956

Dental Barriers and Sleeves (AB0006) by ANI Co., Ltd. — Product Code PEM

K261956 is an FDA 510(k) premarket notification submitted by ANI Co., Ltd. for the device "Dental Barriers and Sleeves (AB0006)". The FDA issued a decision of Substantially Equivalent on September 8, 2026. 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
September 8, 2026
Date Received
June 11, 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 for product code PEM

  • K262073 — Hygienic Protective Bite Cover (2207-010-50) (September 17, 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