Cleared Traditional

K914041 - MIDWEST IMPLANT HEXED 3.3 MM CYLINDER TYPE IMPLANT

K914041 is an FDA 510(k) clearance for MIDWEST IMPLANT HEXED 3.3 MM CYLINDER T..., manufactured by Midwest Implant Sales, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K914041 · Midwest Implant Sales, Inc. · Dental device
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Dec 1991
Decision
90d
Days
Class 2
Risk

K914041 is an FDA 510(k) clearance for the MIDWEST IMPLANT HEXED 3.3 MM CYLINDER TYPE IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Midwest Implant Sales, Inc. (Schaumburg, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Midwest Implant Sales, Inc. devices

FDA 510(k) Submission Details - K914041

510(k) Number K914041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1991
Decision Date December 09, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1324
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