510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180527Substantially Equivalent

Is3

Hiossen, Inc., Fariless Hills PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180527 is the FDA 510(k) clearance record for IS3, a class I device, cleared for Hiossen, Inc. on under FDA product code EKX (Handpiece, Direct Drive, Ac-Powered). FDA records list 26 510(k) clearances for Hiossen, Inc., from to . As of , FDA records show no recalls naming K180527.

Clearance record

Decision date
Received
(77 days to decision)
Product code
EKX Handpiece, Direct Drive, Ac-Powered
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Hiossen, Inc. 85 Ben Fairless Dr., Fariless Hills PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EKX

Trailing 12 months
1 clearance under product code EKX in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EKX, 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 20261
October 20260