Cleared Traditional

K123786 - STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM

K123786 is the FDA 510(k) clearance for STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM by Stryker. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K123786 · Stryker · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
120d
Days
Class 2
Risk

K123786 is an FDA 510(k) clearance for the STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on April 9, 2013 after a review of 120 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 Stryker devices

Submission Details

510(k) Number K123786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2012
Decision Date April 09, 2013
Days to Decision 120 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
7d faster than avg
Panel avg: 127d · This submission: 120d
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 123
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K123786.
LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
K121235 · Stryker · Jan 2014
STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT
K132519 · Stryker · Dec 2013
SMARTBUILDER SYSTEM (SB1)
K130840 · Osstem Implant Co., Ltd. · Sep 2013
STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM
K122313 · Stryker · Oct 2012
SMARTBUILDER SYSTEM
K120951 · Osstem Implant Co., Ltd. · Oct 2012
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · Medtronic Sofamor Danek USA, Inc. · May 2012