Cleared Traditional

K062436 - SIS SINUS IMPLANT STABILIZER

K062436 is an FDA 510(k) clearance for SIS SINUS IMPLANT STABILIZER, manufactured by Mondeal Medical Systems GmbH. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K062436 · Mondeal Medical Systems GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
343d
Days
Class 2
Risk

K062436 is an FDA 510(k) clearance for the SIS SINUS IMPLANT STABILIZER. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Mondeal Medical Systems GmbH (Amsterdam, NL). The FDA issued a Cleared decision on July 30, 2007 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mondeal Medical Systems GmbH devices

FDA 510(k) Submission Details - K062436

510(k) Number K062436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2006
Decision Date July 30, 2007
Days to Decision 343 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
216d slower than avg
Panel avg: 127d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

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 236
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K062436.
SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
K080331 · Synthes (Usa) · Apr 2008
ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
K072528 · Prosurg, Inc. · Dec 2007
MODUS TRILOCK 2.0/2.3/2.5
K071612 · Medartis AG · Sep 2007
XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES
K070737 · Prosurg, Inc. · Jul 2007
THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
K063790 · Synthes (Usa) · Apr 2007
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
K062789 · Synthes (Usa) · Feb 2007