Cleared Traditional

K102641 - MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE (FDA 510(k) Clearance)

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

K102641 · Neoortho Produtos Ortopedicos S/A · Dental device
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Dec 2010
Decision
98d
Days
Class 2
Risk

K102641 is an FDA 510(k) clearance for the MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Neoortho Produtos Ortopedicos S/A (San Diego, US). The FDA issued a Cleared decision on December 20, 2010 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 Neoortho Produtos Ortopedicos S/A devices

Submission Details

510(k) Number K102641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2010
Decision Date December 20, 2010
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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.

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