Cleared Traditional

K103136 - SURGICASE CMF

K103136 is the FDA 510(k) clearance for SURGICASE CMF by Materialise NV. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K103136 · Materialise NV · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
144d
Days
Class 2
Risk

K103136 is an FDA 510(k) clearance for the SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on March 18, 2011 after a review of 144 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 Materialise NV devices

Submission Details

510(k) Number K103136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2010
Decision Date March 18, 2011
Days to Decision 144 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
17d slower than avg
Panel avg: 127d · This submission: 144d
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.

Regulatory Peers - JEY Plate, Bone

All 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K103136.
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · Medtronic Sofamor Danek USA, Inc. · May 2012
RESORB X-G
K112064 · KLS-Martin L.P. · Mar 2012
ARCHITEX SPACE MAINTENANCE SYSTEM
K110259 · Medtronic Sofamor Danek USA, Inc. · Apr 2011
LEFORTE NEURO SYSTEM BONE PLATE
K103778 · Jeil Medical Corporation · Jan 2011
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
K102656 · Synthes (Usa) · Dec 2010
SUSTAIN SPACE MAINTENANCE SYSTEM
K100779 · Medtronic Sofamor Danek USA, Inc. · Dec 2010