Cleared Special

K150182 - Neodent Implant System- CM Drive Implants

K150182 is an FDA 510(k) clearance for Neodent Implant System- CM Drive Implants, 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 Special 510(k) pathway after a 86-day FDA review.

K150182 · Jjgc Industria E Comercio DE Materiais Dentarios S · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
86d
Days
Class 2
Risk

K150182 is an FDA 510(k) clearance for the Neodent Implant System- CM Drive Implants. 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 April 23, 2015 after a review of 86 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150182

510(k) Number K150182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2015
Decision Date April 23, 2015
Days to Decision 86 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
42d faster than avg
Panel avg: 128d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Instradent USA
Christopher Klaczyk

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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