Cleared Traditional

K901923 - INVOTEC POLY-MESH MANDIBULAR TRAY

K901923 is an FDA 510(k) clearance for INVOTEC POLY-MESH MANDIBULAR TRAY, manufactured by Invotec International, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code JAZ cleared through the Traditional 510(k) pathway after a 184-day FDA review.

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

FDA 510(k) Submission Details - K901923

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.

JAZ Device Classification - Class 2, Special Controls

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.