Cleared Traditional

K140934 - HIOSSEN IMPLANT SYSTEM

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

K140934 · Hiossen, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K140934

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
Combination Product No
PCCP Authorized No
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.

DZE Device Classification - Class 2, Special Controls

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 1182
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K140934.
XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM
K140091 · Megagen Implant Co., Ltd. · Dec 2014
TRAUSIM DENTAL IMPLANT SYSTEM
K140202 · Jiangsu Trausim Medical Instrument · Dec 2014
SGS DENTAL IMPLANT
K133362 · Sgs International, Ltd. · Nov 2014
TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM
K140293 · Adin Dental Implants Systems , Ltd. · Oct 2014
KJ EXTERNAL IMPLANT SYSTEM
K140051 · Kj Meditech Co., Ltd. · Oct 2014
J2I IMPLANT SYSTEM
K140052 · Kj Meditech Co., Ltd. · Oct 2014