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510(k) K132953

TIDISHEILD by Tidi Products,Llc — Product Code PEM

K132953 is an FDA 510(k) premarket notification submitted by Tidi Products,Llc for the device "TIDISHEILD". The FDA issued a decision of Substantially Equivalent on February 18, 2014. The device falls under product code PEM (Dental Barriers And Sleeves), a Class II device regulated under 21 CFR 878.4370. Tidi Products,Llc has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2014
Date Received
September 20, 2013
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 Tidi Products,Llc

  • K100800 — TIDI FACEMASK (June 14, 2010)
  • K092580 — TIDI FACEMASK (February 23, 2010)

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)
  • K190484 — BH Medical Dental Barrier Sleeves and Barrier Film (September 10, 2019)
  • K190949 — ScanX Barrier Envelopes (July 26, 2019)

FDA data resources