Cleared Traditional

EK D3.3 and Ultra Wide Implants

K240232 · Hiossen, Inc. · Dental
Sep 2024
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K240232 is an FDA 510(k) clearance for the EK D3.3 and Ultra Wide Implants, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on September 13, 2024, 228 days after receiving the submission on January 29, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K240232 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2024
Decision Date September 13, 2024
Days to Decision 228 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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