510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860058Substantially Equivalent

Denpax

Nissho Iwai American Corp., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860058 is the FDA 510(k) clearance record for DENPAX, a class I device, cleared for Nissho Iwai American Corp. on under FDA product code EBR (Unit, Suction Operatory). FDA records list one 510(k) clearance for Nissho Iwai American Corp. As of , FDA records show no recalls naming K860058.

Clearance record

Decision date
Received
(65 days to decision)
Product code
EBR Unit, Suction Operatory
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Nissho Iwai American Corp. 1211 Ave. Of The Americas, New York NY
Third party review
No

Clearances, product code EBR

Trailing 12 months

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

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