Premium Plus Disposable Barrier Sleeve

FDA 510(k) K163447 · Premium Plus International Limited

Substantially Equivalent

510(k) numberK163447

Submission

Device name
Premium Plus Disposable Barrier Sleeve
Applicant
Premium Plus International Limited
Hong Kong, CN
Received
December 8, 2016
Decision date
June 20, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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.

Other 510(k)s with product code PEM

510(k)DeviceApplicantDecision
K261956Dental Barriers and Sleeves (AB0006)PEM · Traditional ANI Co., Ltd.09/08/2026SE
K250735Dental Barrier and SleevesPEM · Traditional Fomed Industries, Inc.06/10/2025SE
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.

510(k)DeviceDecision
K170261Premium Plus Prophy Air MotorEFB · Abbreviated 10/19/2017SE
K153514Premium Plus C01/C02 LED Curing LightEBZ · Abbreviated 08/22/2016SE
K100854Premium Plus Disposable Prophy Angle Model 3399EGS · Traditional 12/09/2010SE

Questions and answers

When was Premium Plus Disposable Barrier Sleeve cleared by the FDA?

Premium Plus Disposable Barrier Sleeve (K163447) received a 510(k) decision of Substantially Equivalent on June 20, 2017, 194 days after the submission was received.

What is the product code of K163447?

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