510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182009Substantially Equivalent

Dia-Proseal

Diadent Group International, Cheongji-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182009 is the FDA 510(k) clearance record for Dia-Proseal, a class II device, cleared for DiaDent Group International on under FDA product code KIF (Resin, Root Canal Filling). FDA records list 22 510(k) clearances for DiaDent Group International, from to . As of , FDA records show no recalls naming K182009.

Clearance record

Decision date
Received
(426 days to decision)
Product code
KIF Resin, Root Canal Filling
Regulation
21 CFR 872.3820
Device class
Class II
Review panel
Dental
Applicant
DiaDent Group International 16, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu, Cheongji-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KIF

Trailing 12 months
6 clearances under product code KIF in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20262
October 20260