Cleared Traditional

K173902 - Neodent Implant System – GM Line

K173902 is the FDA 510(k) clearance for Neodent Implant System – GM Line by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K173902 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
119d
Days
Class 2
Risk

K173902 is an FDA 510(k) clearance for the Neodent Implant System – GM Line. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Jjgc Industria E Comercio DE Materiais Dentarios S.A. (Curitiba, BR). The FDA issued a Cleared decision on April 20, 2018 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 Jjgc Industria E Comercio DE Materiais Dentarios S.A. devices

Submission Details

510(k) Number K173902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2017
Decision Date April 20, 2018
Days to Decision 119 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
8d faster than avg
Panel avg: 127d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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

PaxMed International, LLC
Kevin A. Thomas

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 - NHA Abutment, Implant, Dental, Endosseous

All 480
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K173902.
ArgenIS Titanium Abutments
K172430 · Argen Corporation · May 2018
Dentium Implantium & SuperLine Prosthetics
K172640 · Dentium Co., Ltd. · May 2018
3.0 Dynamic TiBase
K162021 · Talladium Espana, SL · May 2018
OT EQUATOR
K171409 · Rhein 83 Srl · Apr 2018
Straumann Variobase for Crown AS
K173379 · Institut Straumann AG · Mar 2018
CCM Abutment System
K173120 · Innobiosurg Co., Ltd. · Mar 2018