Cleared Traditional

Neodent Implant System - Zirconia Implant System (K231803) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231803 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Dental device
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Dec 2023
Decision
176d
Days
Class 2
Risk

K231803 is an FDA 510(k) clearance for the Neodent Implant System - Zirconia Implant System. 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 Ind?stria e Com?rcio de Materiais Dent?rios S.A. (Curitiba, BR). The FDA issued a Cleared decision on December 13, 2023 after a review of 176 days - an extended review cycle.

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 Ind?stria e Com?rcio de Materiais Dent?rios S.A. devices

Submission Details

510(k) Number K231803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2023
Decision Date December 13, 2023
Days to Decision 176 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
49d slower than avg
Panel avg: 127d · This submission: 176d
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 Peers - NHA Abutment, Implant, Dental, Endosseous

All 318
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K231803.
Elos Accurate Customized Abutment
K231307 · Elos Medtech Pinol A/S · Dec 2023
INNO SLA Submerged Hybrid Ti-Base System
K231411 · Cowellmedi Co., Ltd. · Dec 2023
Angled Abutment
K232560 · Arum Dentistry Co., Ltd. · Dec 2023
BTI Interna Prosthetic Components
K232750 · B.T.I. Biotechnology Institute, Sl. · Dec 2023
SS Abutment System
K232220 · Osstem Implant Co., Ltd. · Dec 2023
Meta G UCLA Abutment
K232546 · Cowellmedi Co., Ltd. · Nov 2023