510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163447Substantially Equivalent

Premium Plus Disposable Barrier Sleeve

Premium Plus International Limited, Hong Kong, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163447 is the FDA 510(k) clearance record for Premium Plus Disposable Barrier Sleeve, a class II device, cleared for Premium Plus International Limited on under FDA product code PEM (Dental Barriers And Sleeves). FDA's definition for product code PEM reads: "Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients". FDA records list 4 510(k) clearances for Premium Plus International Limited, from to . As of , FDA records show no recalls naming K163447.

Clearance record

Decision date
Received
(194 days to decision)
Product code
PEM Dental Barriers And Sleeves
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Premium Plus International Limited Flat 1001 Yuen Long Trading Centre, 33 Wang Yip St. W., Hong Kong, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PEM

Trailing 12 months
2 clearances under product code PEM in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code PEM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20262
October 20260