Home / 510(k) Clearances / K190484

510(k) K190484

BH Medical Dental Barrier Sleeves and Barrier Film by Bh Medical Products Co., Ltd. — Product Code PEM

K190484 is an FDA 510(k) premarket notification submitted by Bh Medical Products Co., Ltd. for the device "BH Medical Dental Barrier Sleeves and Barrier Film". The FDA issued a decision of Substantially Equivalent on September 10, 2019. The device falls under product code PEM (Dental Barriers And Sleeves), a Class II device regulated under 21 CFR 878.4370. Bh Medical Products Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2019
Date Received
February 27, 2019
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 Bh Medical Products Co., Ltd.

  • K172280 — BH Sterilization Pouch (August 3, 2018)
  • K133070 — SURGICAL FACE MASK (Ear Loops and Tie-on) (June 22, 2015)

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)
  • K201604 — Plasdent Disposable Barrier Sleeves and Barrier Film (December 23, 2020)
  • K191448 — Barrier Sleeves (October 8, 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