510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822464Substantially Equivalent

Obturation Gutta

U.S. Shizai Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822464 is the FDA 510(k) clearance record for OBTURATION GUTTA, a class I device, cleared for U.S. Shizai Corp. on under FDA product code EKA (File, Margin Finishing, Operative). FDA records list 5 510(k) clearances for U.S. Shizai Corp., from to . As of , FDA records show no recalls naming K822464.

Clearance record

Decision date
Received
(79 days to decision)
Product code
EKA File, Margin Finishing, Operative
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
U.S. Shizai Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code EKA

Trailing 12 months

FDA records hold no clearances under product code EKA in the trailing twelve months.

FDA records show no clearances under product code EKA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EKA, 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 20260
October 20260