Cleared Traditional

K150388 - Dental Implant System

K150388 is an FDA 510(k) clearance for Dental Implant System, manufactured by Bio Concept Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K150388 · Bio Concept Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
267d
Days
Class 2
Risk

K150388 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 Bio Concept Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on November 12, 2015 after a review of 267 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 Bio Concept Co., Ltd. devices

FDA 510(k) Submission Details - K150388

510(k) Number K150388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2015
Decision Date November 12, 2015
Days to Decision 267 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
139d slower than avg
Panel avg: 128d · This submission: 267d
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 Consultant

Mid-Link Consulting Co, Ltd.
DIANA HONG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1371
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K150388.
TRI Dental Implant System
K151916 · Tri Dental Implants Int. AG · Dec 2015
OneQ-SL Implant System
K142313 · Dentis Co., Ltd. · Dec 2015
3i T3 Short Implants
K150571 · Biomet 3i · Nov 2015
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