Cleared Traditional

K140934 - HIOSSEN IMPLANT SYSTEM

K140934 is the FDA 510(k) clearance for HIOSSEN IMPLANT SYSTEM by Hiossen, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K140934 · Hiossen, Inc. · Dental device
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Nov 2014
Decision
215d
Days
Class 2
Risk

K140934 is an FDA 510(k) clearance for the HIOSSEN IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on November 12, 2014 after a review of 215 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Hiossen, Inc. devices

Submission Details

510(k) Number K140934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2014
Decision Date November 12, 2014
Days to Decision 215 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 127d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 589
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K140934.
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K133731 · Nobel Biocare AB · May 2014
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K133339 · Zimmer Dental, Inc. · Mar 2014