Cleared Traditional

K123022 - NEODENT IMPLANT SYSTEM

K123022 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 231-day FDA review.

K123022 · 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
May 2013
Decision
231d
Days
Class 2
Risk

K123022 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 May 17, 2013 after a review of 231 days - an extended review cycle.

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. 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.

FDA 510(k) Submission Details - K123022

510(k) Number K123022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2012
Decision Date May 17, 2013
Days to Decision 231 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
103d slower than avg
Panel avg: 128d · This submission: 231d
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 1424
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K123022.
QUANTUM DENTAL IMPLANT SYSTEM
K130787 · Quantum Bioengineering, Ltd. · Jun 2013
DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
K122519 · Dio Corporation · May 2013
ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM
K122804 · Intai Technology Corp. · May 2013
REVOIS PRO IMPLANT STSYEM
K113539 · Riemser Arzneimittel AG · May 2013
ZUGA DENTAL IMPLANT SYSTEM
K122664 · Zuga Medical, Inc. · Apr 2013
STRAUMANN DENTAL IMPLANT SYSTEM
K130222 · Straumann USA, LLC · Apr 2013