Tidisheild

FDA 510(k) K132953 · Tidi Products,Llc

Substantially Equivalent

510(k) numberK132953

Submission

Device name
Tidisheild
Applicant
Tidi Products,Llc
Neenah, WI, US
Received
September 20, 2013
Decision date
February 18, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
PEM – Dental Barriers And Sleeves
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4370
Specialty
General, Plastic Surgery

Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.

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K261956Dental Barriers and Sleeves (AB0006)PEM · Traditional ANI Co., Ltd.09/08/2026SE
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K250606Dental Barrier and SleevesPEM · Traditional Yueying Medical Instruments (Langfang) Co., Ltd.05/29/2025SE
K242435Dental Barrier and SleevesPEM · Traditional Wellmed Dental Medical Supply Co., Ltd.10/18/2024SE
K233918Dental Barrier and SleevesPEM · Traditional Yongqing Huaguan Dental Instruments Factory05/09/2024SE
K220662Disposable Barrier SleevesPEM · Traditional Premium Plus (Dongguan) Limited05/11/2022SE
K211026Minitube Dentasleeve Protective Barrier SleevesPEM · Traditional Minitube AB08/03/2021SE
K201604Plasdent Disposable Barrier Sleeves and Barrier FilmPEM · Traditional Plasdent Corporation12/23/2020SE
K191448Barrier SleevesPEM · Traditional Ivoclar Vivadent, AG10/08/2019SE
K190484BH Medical Dental Barrier Sleeves and Barrier FilmPEM · Traditional Bh Medical Products Co., Ltd.09/10/2019SE

More from Bh Medical Products Co., Ltd.

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Questions and answers

When was Tidisheild cleared by the FDA?

Tidisheild (K132953) received a 510(k) decision of Substantially Equivalent on February 18, 2014, 151 days after the submission was received.

What is the product code of K132953?

The FDA product code is PEM – Dental Barriers And Sleeves, a Class II (moderate risk) device regulated under 21 CFR 878.4370.