Cleared Traditional

K101945 - NEODENT IMPLANT SYSTEM

K101945 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 198-day FDA review.

K101945 · 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
Jan 2011
Decision
198d
Days
Class 2
Risk

K101945 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 January 26, 2011 after a review of 198 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 - K101945

510(k) Number K101945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2010
Decision Date January 26, 2011
Days to Decision 198 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
70d slower than avg
Panel avg: 128d · This submission: 198d
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 K101945.
ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM
K101913 · Anthogyr Sas · Mar 2011
ET III SA ULTRA WIDE SYSTEM
K103537 · Hiossen, Inc. · Mar 2011
ASTRA TECH IMPLANT SYSTEM
K101732 · Astra Tech AB · Feb 2011
PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1
K101225 · Promimic AB · Jan 2011
IMPLANT-ONE SYSTEM
K102822 · Custom Dental Implants, Inc. · Jan 2011
CERAROOT IMPLANT SYSTEM
K093595 · Oral Iceberg S.L. · Jan 2011