Cleared Traditional

K152555 - Dental Implant System

K152555 is an FDA 510(k) clearance for Dental Implant System, manufactured by Ariabio International, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K152555 · Ariabio International, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
156d
Days
Class 2
Risk

K152555 is an FDA 510(k) clearance for the Dental Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ariabio International, Inc. (Los Angeles, US). The FDA issued a Cleared decision on February 11, 2016 after a review of 156 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 Ariabio International, Inc. devices

FDA 510(k) Submission Details - K152555

510(k) Number K152555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2015
Decision Date February 11, 2016
Days to Decision 156 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
29d slower than avg
Panel avg: 127d · This submission: 156d
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 833
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K152555.
OneQ-SL s-Clean Implant System
K153639 · Dentis Co., Ltd. · Apr 2016
Straumann Bone Level Tapered Implants
K153758 · Institut Straumann AG · Mar 2016
NobelZygoma 45°
K152093 · Nobel Biocare AB · Mar 2016
PURE Ceramic Implants
K151328 · Straumann USA · Jan 2016
OneQ-SL Implant System
K142313 · Dentis Co., Ltd. · Dec 2015
Dentis Dental Implant System
K150344 · Dentis Co., Ltd. · Jul 2015