Cleared Traditional

K121098 - HERO I DENTAL IMPLANT SYSTEM

K121098 is an FDA 510(k) clearance for HERO I DENTAL IMPLANT SYSTEM, manufactured by Kj Meditech Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K121098 · Kj Meditech Co., Ltd. · Dental device
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Jan 2013
Decision
281d
Days
Class 2
Risk

K121098 is an FDA 510(k) clearance for the HERO I DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Kj Meditech Co., Ltd. (Fullerton, US). The FDA issued a Cleared decision on January 17, 2013 after a review of 281 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 Kj Meditech Co., Ltd. devices

FDA 510(k) Submission Details - K121098

510(k) Number K121098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2012
Decision Date January 17, 2013
Days to Decision 281 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
154d slower than avg
Panel avg: 127d · This submission: 281d
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 797
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K121098.
STRAUMANN DENTAL IMPLANT SYSTEM
K123784 · Straumann USA, LLC · Apr 2013
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K123870 · Megagen Implant Co., Ltd. · Mar 2013
INCLUSIVE TAPERED IMPLANT SYSTEM
K121406 · Prismatik Dentalcraft, Inc. · Feb 2013
TS IMPLANT SYSTEM
K121585 · Osstem Implant Co., Ltd. · Jan 2013
TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
K122855 · Straumann USA · Dec 2012
TS FIXTURE SYSTEM
K121995 · Osstem Implant Co., Ltd. · Nov 2012