Cleared Traditional

K142174 - BIOMATE DENTAL IMPLANT SYSTEM

K142174 is an FDA 510(k) clearance for BIOMATE DENTAL IMPLANT SYSTEM, manufactured by Biomate Medical Devices Technology Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K142174 · Biomate Medical Devices Technology Co., Ltd. · Dental device
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Mar 2015
Decision
225d
Days
Class 2
Risk

K142174 is an FDA 510(k) clearance for the BIOMATE DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biomate Medical Devices Technology Co., Ltd. (Kaohsiung County, TW). The FDA issued a Cleared decision on March 20, 2015 after a review of 225 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 Biomate Medical Devices Technology Co., Ltd. devices

FDA 510(k) Submission Details - K142174

510(k) Number K142174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2014
Decision Date March 20, 2015
Days to Decision 225 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
98d slower than avg
Panel avg: 127d · This submission: 225d
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 1186
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K142174.
J2A Dental Implant System, J2C Dental Implant System
K150060 · Kj Meditech Co., Ltd. · Apr 2015
EBI External Implant System
K142426 · Ebi, Inc. · Mar 2015
IBS IMPLANT SYSTEM
K140806 · Innobiosurg Co., Ltd. · Mar 2015
KONUS DENTAL IMPLANT SYSTEM
K141159 · Argon Med. Productions Vertriebs Gesellschaft Mbh · Mar 2015
PREMIUM, SHELTA Implant Systems
K142242 · Sweden & Martina S.P.A. · Feb 2015
WINSIX Implant System
K133733 · Biosaf IN S.R.L. · Jan 2015