Cleared Traditional

K141777 - NEODENT IMPLANT SYSTEM

K141777 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 383-day FDA review.

K141777 · Jjgc Industria E Comercio DE Materiais Dentarios S · Dental device
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Jul 2015
Decision
383d
Days
Class 2
Risk

K141777 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 (San Diego, US). The FDA issued a Cleared decision on July 20, 2015 after a review of 383 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.

View all Jjgc Industria E Comercio DE Materiais Dentarios S devices

FDA 510(k) Submission Details - K141777

510(k) Number K141777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2014
Decision Date July 20, 2015
Days to Decision 383 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
256d slower than avg
Panel avg: 127d · This submission: 383d
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 K141777.
Dentis Dental Implant System
K150344 · Dentis Co., Ltd. · Jul 2015
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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