Cleared Traditional

K133285 - STRYKER TEMPORARY CONDYLAR PROSTHESIS

K133285 is the FDA 510(k) clearance for STRYKER TEMPORARY CONDYLAR PROSTHESIS by Stryker. It is a Class 2 Dental device (product code NEI) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K133285 · Stryker · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
166d
Days
Class 2
Risk

K133285 is an FDA 510(k) clearance for the STRYKER TEMPORARY CONDYLAR PROSTHESIS. Classified as Prosthesis, Condyle, Mandibular, Temporary (product code NEI), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on April 9, 2014 after a review of 166 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4770 - 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 K133285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date April 09, 2014
Days to Decision 166 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
39d slower than avg
Panel avg: 127d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEI Prosthesis, Condyle, Mandibular, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4770
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 - NEI Prosthesis, Condyle, Mandibular, Temporary

Devices cleared under the same product code (NEI) and FDA review panel - the closest regulatory comparables to K133285.
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