Cleared Traditional

Stryker Facial iD System (K232350) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232350 · Stryker Craniomaxillofacial · Dental device
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Jan 2024
Decision
159d
Days
Class 2
Risk

K232350 is an FDA 510(k) clearance for the Stryker Facial iD System. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker Craniomaxillofacial (Portage, US). The FDA issued a Cleared decision on January 13, 2024 after a review of 159 days - an extended review cycle.

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 Craniomaxillofacial devices

Submission Details

510(k) Number K232350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2023
Decision Date January 13, 2024
Days to Decision 159 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
32d slower than avg
Panel avg: 127d · This submission: 159d
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 97
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K232350.
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K222650 · Stryker Craniomaxillofacial (Cmf) · Dec 2022