Cleared Traditional

K953158 - HAWN UNIVERSAL

K953158 is an FDA 510(k) clearance for HAWN UNIVERSAL, manufactured by Metal-Tech. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K953158 · Metal-Tech · Dental device
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Oct 1995
Decision
113d
Days
Class 2
Risk

K953158 is an FDA 510(k) clearance for the HAWN UNIVERSAL. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Metal-Tech (Lovettsville, US). The FDA issued a Cleared decision on October 5, 1995 after a review of 113 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 Metal-Tech devices

FDA 510(k) Submission Details - K953158

510(k) Number K953158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1995
Decision Date October 05, 1995
Days to Decision 113 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
14d faster than avg
Panel avg: 127d · This submission: 113d
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 1315
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K953158.
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K952917 · Steri-Oss, Inc. · Oct 1995
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K946311 · Calcitek, Inc. · Oct 1995
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K953435 · Nobelpharma USA, Inc. · Oct 1995
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM)
K950204 · Implant Innovations, Inc. · Sep 1995