Cleared Traditional

K182305 - Stryker Facial iD Plating System

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

K182305 · Stryker · Dental device
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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

Submission Details

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.

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 K182305.
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K180204 · Visionare, LLC · Dec 2018
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K180249 · Matrix Surgical Holdings, LLC/Matrix Surgical USA · Oct 2018
KLS Martin Individual Patient Solutions
K180962 · KLS-Martin L.P. · Aug 2018