510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K901037Substantially Equivalent

Visioner 21-a

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

K901037 is the FDA 510(k) clearance record for VISIONER 21-A, a class I device, cleared for J. Morita USA, Inc. on under FDA product code EKS (File, Pulp Canal, Endodontic). FDA records list 52 510(k) clearances for J. Morita USA, Inc., from to . As of , FDA records show no recalls naming K901037.

Clearance record

Decision date
Received
(161 days to decision)
Product code
EKS File, Pulp Canal, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
J. Morita USA, Inc. 9 Mason, Irvine CA
Third party review
No

Clearances, product code EKS

Trailing 12 months

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

FDA records show no clearances under product code EKS in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EKS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260