Cleared Traditional

SCREW, BONE, MAXILLOFACIAL (K911165) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911165 · Tekno-Medical · Dental device
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Aug 1991
Decision
158d
Days
Class 2
Risk

K911165 is an FDA 510(k) clearance for the SCREW, BONE, MAXILLOFACIAL. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Tekno-Medical (Tarzana, US). The FDA issued a Cleared decision on August 20, 1991 after a review of 158 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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.

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Submission Details

510(k) Number K911165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1991
Decision Date August 20, 1991
Days to Decision 158 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 127d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 - DZL Screw, Fixation, Intraosseous

All 31
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K911165.
SMF TITANIUM (TI) ALLOY BONE SCREWS
K963546 · Synthes (Usa) · Jun 1997
SMF STAINLESS STEEL BONE SCREWS
K964261 · Synthes (Usa) · Apr 1997
MEMFIX SCREWS
K910427 · W.L. Gore & Associates, Inc. · Sep 1991
LEW PROSTHETIC LOCKING DEVICE
K770131 · Howmedica Corp. · Jan 1977
LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM
K761228 · Howmedica Corp. · Dec 1976