510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242435Substantially Equivalent

Dental Barrier and Sleeves

Wellmed Dental Medical Supply Co., Ltd, Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K242435 is the FDA 510(k) clearance record for Dental Barrier and Sleeves, a class II device, cleared for Wellmed Dental Medical Supply Co., Ltd. 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 3 510(k) clearances for Wellmed Dental Medical Supply Co., Ltd., from to . As of , FDA records show no recalls naming K242435.

Clearance record

Decision date
Received
(63 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
Wellmed Dental Medical Supply Co., Ltd. 301 Zhongxin Science And Technology Bldg., #64,, Shenzhen, CN
510(k) summary
Statement
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