Cleared Traditional

K103084 - NEODENT GRAFT SCREW (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103084 · Jjgc Industria E Comercio DE Materiais Dentarios S · Dental device
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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.

View all Jjgc Industria E Comercio DE Materiais Dentarios S devices

Submission Details

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
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 127d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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
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