Cleared Traditional

IS3

K180527 · Hiossen, Inc. · Dental
May 2018
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K180527 is an FDA 510(k) clearance for the IS3, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on May 16, 2018, 77 days after receiving the submission on February 28, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K180527 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2018
Decision Date May 16, 2018
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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