Cleared Special

Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants (K193592) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K193592 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Dental device
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Apr 2020
Decision
127d
Days
Class 2
Risk

K193592 is an FDA 510(k) clearance for the Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants. Classified as Implant, Endosseous, Root-form (product code DZE), 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 28, 2020 after a review of 127 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Jjgc Industria E Comercio DE Materiais Dentarios S.A. devices

Submission Details

510(k) Number K193592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date April 28, 2020
Days to Decision 127 days
Submission Type Special
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
At panel average
Panel avg: 127d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 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.

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