Cleared Traditional

K901923 - INVOTEC POLY-MESH MANDIBULAR TRAY (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901923 · Invotec International, Inc. · Ear, Nose, Throat device
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Oct 1990
Decision
184d
Days
Class 2
Risk

K901923 is an FDA 510(k) clearance for the INVOTEC POLY-MESH MANDIBULAR TRAY. Classified as Prosthesis, Facial, Mandibular Implant (product code JAZ), Class II - Special Controls.

Submitted by Invotec International, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 31, 1990 after a review of 184 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3695 - the FDA ear, nose and throat device 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Invotec International, Inc. devices

Submission Details

510(k) Number K901923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1990
Decision Date October 31, 1990
Days to Decision 184 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 89d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAZ Prosthesis, Facial, Mandibular Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3695
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 Ear, Nose, Throat devices follow this clearance model.