Cleared Traditional

K150199 - Neodent Implant System

K150199 is an FDA 510(k) clearance for Neodent Implant System, manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K150199 · Jjgc Industria E Comercio DE Materiais Dentarios S · Dental device
Download Printable Device Report (PDF)
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Jun 2015
Decision
137d
Days
Class 2
Risk

K150199 is an FDA 510(k) clearance for the Neodent Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Jjgc Industria E Comercio DE Materiais Dentarios S (Curitiba, BR). The FDA issued a Cleared decision on June 15, 2015 after a review of 137 days - within the typical 510(k) review window.

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 Jjgc Industria E Comercio DE Materiais Dentarios S devices

FDA 510(k) Submission Details - K150199

510(k) Number K150199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2015
Decision Date June 15, 2015
Days to Decision 137 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
10d slower than avg
Panel avg: 127d · This submission: 137d
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 832
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K150199.
Dentis Dental Implant System
K150344 · Dentis Co., Ltd. · Jul 2015
Straumann® Dental Implant System ¿ Roxolid® SLA Implants
K150938 · Straumann USA, LLC · Jul 2015
MiNi Internal Implant System
K150537 · Megagen Implant Co., Ltd. · Jul 2015
NobelActive
K142260 · Nobel Biocare AB · May 2015
Hahn Tapered Implant System
K143353 · Prismatik Dentalcraft, Inc. · Apr 2015
BioHorizons Tapered Internal Implants
K143022 · BioHorizons Implant Systems, Inc. · Jan 2015