Cleared Traditional

K222026 - Neodent Implant System - Zirconia Impla...

K222026 is the FDA 510(k) clearance for Neodent Implant System - Zirconia Impla... 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 368-day FDA review.

K222026 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Dental device
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Jul 2023
Decision
368d
Days
Class 2
Risk

K222026 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 Industria E Comercio DE Materiais Dentarios S.A. (Curitiba, BR). The FDA issued a Cleared decision on July 14, 2023 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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.A. devices

Submission Details

510(k) Number K222026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2022
Decision Date July 14, 2023
Days to Decision 368 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
241d slower than avg
Panel avg: 127d · This submission: 368d
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

Straumann USA, LLC
Jennifer M. Jackson

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 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K222026.
Dentis s-Clean Regular Abutment
K230126 · Dentis Co., Ltd. · Aug 2023
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
K230873 · Southern Implants (Pty), Ltd. · Aug 2023
Bonafix TiBase
K221673 · Zentek Medical, LLC · Jul 2023
Dentis i-Clean System
K230307 · Dentis Co., Ltd. · Jul 2023
SMARTbase Abutment System
K223535 · Implant Direct Sybron Manufacturing, LLC · Jun 2023
Dentis s-Clean SQ-SL Narrow Implant System
K230246 · Dentis Co., Ltd. · May 2023