Cleared Traditional

K051871 - STOMA BONE SCREW

K051871 is an FDA 510(k) clearance for STOMA BONE SCREW, manufactured by Storz AM Mark GmbH. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K051871 · Storz AM Mark GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
108d
Days
Class 2
Risk

K051871 is an FDA 510(k) clearance for the STOMA BONE SCREW. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Storz AM Mark GmbH (Mühlheim An Der Donau, DE). The FDA issued a Cleared decision on October 27, 2005 after a review of 108 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K051871

510(k) Number K051871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2005
Decision Date October 27, 2005
Days to Decision 108 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 128d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZL Device Classification - Class 2, Special Controls

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 80
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K051871.
STOMA BONE BLOCK SCREW
K080430 · Storz AM Mark GmbH · Nov 2008
SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW
K073342 · Salvin Dental Specialties, Inc. · Mar 2008
ALPHA BIO BONE FIXATION SCREW SYSTEM
K063769 · Alpha-Bio Tec , Ltd. · Mar 2007
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
K050606 · Synthes (Usa) · Apr 2005
BONE BLOCK FIXATION SET
K050515 · Straumann USA, Inc. · Apr 2005
STRYKER MMF SCREW
K050535 · Stryker Instruments · Mar 2005
K051871 · STOMA BONE SCREW
Download PDF FDA Summary Storz AM Mark GmbH