Cleared Traditional

K142557 - Anker Dental Implant System - SB-III, ST and AT series

K142557 is an FDA 510(k) clearance for Anker Dental Implant System - SB-III, manufactured by Alliance Global Technology Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K142557 · Alliance Global Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
375d
Days
Class 2
Risk

K142557 is an FDA 510(k) clearance for the Anker Dental Implant System - SB-III, ST and AT series. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Alliance Global Technology Co., Ltd. (Kaohsiung City, TW). The FDA issued a Cleared decision on September 21, 2015 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K142557

510(k) Number K142557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2014
Decision Date September 21, 2015
Days to Decision 375 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
247d slower than avg
Panel avg: 128d · This submission: 375d
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 1424
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K142557.
JDENTALCARE Implant System
K143142 · Jdentalcare Srl · Nov 2015
PUR Dental Implant System
K151928 · Sterngold Dental, LLC · Nov 2015
iSy Implant System
K151599 · Altatec GmbH · Oct 2015
Dental Implant OKTAGON Bone Level
K143539 · Hager& Meisinger GmbH · Aug 2015
Implanova
K150040 · Dental Evolutions, Inc. · Aug 2015
PerioType Rapid
K143758 · Clinical House Europe GmbH · Aug 2015