510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261956Substantially Equivalent

Dental Barriers and Sleeves (AB0006)

ANI Co., Ltd., Suwon-Si, Gyeonggi-Do, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(89 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
ANI Co., Ltd. 4f, Bldg. B, Suwon-Si, Gyeonggi-Do, KR
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