510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790193Substantially Equivalent

Mizzy Syrijet Mark IV

Mizzy, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790193 is the FDA 510(k) clearance record for MIZZY SYRIJET MARK IV, a class II device, cleared for Mizzy, Inc. on under FDA product code EGM (Injector, Jet, Mechanical-Powered). FDA records list one 510(k) clearance for Mizzy, Inc. As of , FDA records show no recalls naming K790193.

Clearance record

Decision date
Received
(87 days to decision)
Product code
EGM Injector, Jet, Mechanical-Powered
Regulation
21 CFR 872.4475
Device class
Class II
Review panel
Dental
Applicant
Mizzy, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code EGM

Trailing 12 months

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

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