Cleared Special

K090260 - MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS

K090260 is an FDA 510(k) clearance for MODIFICATION TO:STRAUMANN GUIDED INSTRU..., manufactured by Straumann Manufacturing, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 23-day FDA review.

K090260 · Straumann Manufacturing, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
23d
Days
Class 2
Risk

K090260 is an FDA 510(k) clearance for the MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Straumann Manufacturing, Inc. (Andover, US). The FDA issued a Cleared decision on February 26, 2009 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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.

View all Straumann Manufacturing, Inc. devices

FDA 510(k) Submission Details - K090260

510(k) Number K090260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2009
Decision Date February 26, 2009
Days to Decision 23 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 127d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 930
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K090260.
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K083586 · Dentis Co., Ltd. · Apr 2009
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STRAUMANN DENTAL IMPLANT SYSTEM
K083550 · Straumann USA · Feb 2009
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K081419 · Institut Straumann AG · Feb 2009
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MS SYSTEM
K083067 · Osstem Implant Co., Ltd. · Feb 2009