Cleared Traditional

K182305 - Stryker Facial iD Plating System

K182305 is an FDA 510(k) clearance for Stryker Facial iD Plating System, manufactured by Stryker. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K182305 · Stryker · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
136d
Days
Class 2
Risk

K182305 is an FDA 510(k) clearance for the Stryker Facial iD Plating System. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on January 7, 2019 after a review of 136 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

FDA 510(k) Submission Details - K182305

510(k) Number K182305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2018
Decision Date January 07, 2019
Days to Decision 136 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
9d slower than avg
Panel avg: 127d · This submission: 136d
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 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K182305.
KLS Martin Individual Patient Solutions
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K182609 · Delphos Implants - Ind.Com. Importacao E Exportacao DE · Mar 2019
CranioMaxillofacial Fixation (CMF) System - CMF Visionare
K180204 · Visionare, LLC · Dec 2018
OmniPore DUROMAX Surgical Implants
K180249 · Matrix Surgical Holdings, LLC/Matrix Surgical USA · Oct 2018
KLS Martin Individual Patient Solutions
K180962 · KLS-Martin L.P. · Aug 2018