510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K040117Substantially Equivalent

Uniport Self-Contained Portable Dental Unit

Arrow Industries, LLC, Neche ND / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040117 is the FDA 510(k) clearance record for UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT, a class I device, cleared for Arrow Industries, LLC on under FDA product code EIA (Unit, Operative Dental). FDA records list one 510(k) clearance for Arrow Industries, LLC. As of , FDA records show no recalls naming K040117.

Clearance record

Decision date
Received
(92 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Arrow Industries, LLC 530 5th St., Neche ND
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EIA

Trailing 12 months
2 clearances under product code EIA in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EIA, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260