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
K213477Substantially Equivalent

Root ZX3

J. Morita USA, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213477 is the FDA 510(k) clearance record for Root ZX3, a class II device, cleared for J. Morita USA, Inc. on under FDA product code EKZ (Unit, Electrosurgical, And Accessories, Dental). FDA records list 52 510(k) clearances for J. Morita USA, Inc., from to . As of , FDA records show no recalls naming K213477.

Clearance record

Decision date
Received
(278 days to decision)
Product code
EKZ Unit, Electrosurgical, And Accessories, Dental
Regulation
21 CFR 872.4920
Device class
Class II
Review panel
Dental
Applicant
J. Morita USA, Inc. 9 Mason, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EKZ

Trailing 12 months

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

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