Cleared Traditional

K103084 - NEODENT GRAFT SCREW

K103084 is an FDA 510(k) clearance for NEODENT GRAFT SCREW, manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K103084 · 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
Feb 2011
Decision
118d
Days
Class 2
Risk

K103084 is an FDA 510(k) clearance for the NEODENT GRAFT SCREW. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Jjgc Industria E Comercio DE Materiais Dentarios S (San Diego, US). The FDA issued a Cleared decision on February 14, 2011 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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 - K103084

510(k) Number K103084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2010
Decision Date February 14, 2011
Days to Decision 118 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
10d faster than avg
Panel avg: 128d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZL Device Classification - Class 2, Special Controls

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 - DZL Screw, Fixation, Intraosseous

All 79
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K103084.
JUGGERKNOT MINI SOFT ANCHOR
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K130682 · Hager& Meisinger GmbH · Aug 2013
J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
K101902 · Jeil Medical Corporation · Feb 2011
SALVIN DENTAL SPECIALTIES FIXATION SCREW
K100182 · Salvin Dental Specialties, Inc. · May 2010
PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#
K093719 · Osteogenics Biomedical, Inc. · Mar 2010