Cleared Special

K050515 - BONE BLOCK FIXATION SET

K050515 is an FDA 510(k) clearance for BONE BLOCK FIXATION SET, manufactured by Straumann USA, Inc.. The device is a Class 2 Dental device with product code DZL cleared through the Special 510(k) pathway after a 35-day FDA review.

K050515 · Straumann USA, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
35d
Days
Class 2
Risk

K050515 is an FDA 510(k) clearance for the BONE BLOCK FIXATION SET. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Straumann USA, Inc. (Waltham, US). The FDA issued a Cleared decision on April 5, 2005 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050515

510(k) Number K050515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2005
Decision Date April 05, 2005
Days to Decision 35 days
Submission Type Special
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
93d faster than avg
Panel avg: 128d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

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 K050515.
ALPHA BIO BONE FIXATION SCREW SYSTEM
K063769 · Alpha-Bio Tec , Ltd. · Mar 2007
STOMA BONE SCREW
K051871 · Storz AM Mark GmbH · Oct 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
K050606 · Synthes (Usa) · Apr 2005
STRYKER MMF SCREW
K050535 · Stryker Instruments · Mar 2005
KLS MARTIN DRILL-FREE MMF SCREW
K042573 · KLS-Martin L.P. · Oct 2004
SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS
K041887 · Synthes (Usa) · Aug 2004
K050515 · BONE BLOCK FIXATION SET
Download PDF FDA Summary Straumann USA, Inc.