Cleared Traditional

K080430 - STOMA BONE BLOCK SCREW

K080430 is an FDA 510(k) clearance for STOMA BONE BLOCK 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 276-day FDA review.

K080430 · Storz AM Mark GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
276d
Days
Class 2
Risk

K080430 is an FDA 510(k) clearance for the STOMA BONE BLOCK SCREW. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Storz AM Mark GmbH (Emmingen-Liptingen, DE). The FDA issued a Cleared decision on November 21, 2008 after a review of 276 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.

View all Storz AM Mark GmbH devices

FDA 510(k) Submission Details - K080430

510(k) Number K080430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2008
Decision Date November 21, 2008
Days to Decision 276 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 127d · This submission: 276d
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 63
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K080430.
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