510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160232Substantially Equivalent

Disposable Barrier Sleeves and Covers

Dentsply International, Inc., York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160232 is the FDA 510(k) clearance record for Disposable Barrier Sleeves and Covers, a class II device, cleared for Dentsply International, Inc. 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 59 510(k) clearances for Dentsply International, Inc., from to . As of , FDA records show no recalls naming K160232.

Clearance record

Decision date
Received
(127 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
Dentsply International, Inc. 221 W. Philadephia St., Suite 60, York PA
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