510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K830763Substantially Equivalent

Fr Root Canal Filler

Shizai Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830763 is the FDA 510(k) clearance record for FR ROOT CANAL FILLER, a class II device, cleared for Shizai Corp. on under FDA product code KIF (Resin, Root Canal Filling). FDA records list 2 510(k) clearances for Shizai Corp., from to . As of , FDA records show no recalls naming K830763.

Clearance record

Decision date
Received
(169 days to decision)
Product code
KIF Resin, Root Canal Filling
Regulation
21 CFR 872.3820
Device class
Class II
Review panel
Dental
Applicant
Shizai Corp. 803 N. Front St. Suite 3, Mchenry IL
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