Cleared Special

K061176 - STRAUMANN DENTAL IMPLANTS

K061176 is an FDA 510(k) clearance for STRAUMANN DENTAL IMPLANTS, manufactured by Institut Straumann AG. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 106-day FDA review.

K061176 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
106d
Days
Class 2
Risk

K061176 is an FDA 510(k) clearance for the STRAUMANN DENTAL IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Institut Straumann AG (Andover, US). The FDA issued a Cleared decision on August 11, 2006 after a review of 106 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K061176

510(k) Number K061176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2006
Decision Date August 11, 2006
Days to Decision 106 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
22d faster than avg
Panel avg: 128d · This submission: 106d
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 1548
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K061176.
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16
K062281 · Zimmer Dental, Inc. · Sep 2006
SM IMPLANT SYSTEMS
K061797 · Dio Department Dsi, Inc. · Sep 2006
STRAUMANN NARROW NECK IMPLANTS
K060958 · Straumann USA · Aug 2006
ENHANCE DENTAL IMPLANT SYSTEM
K061335 · Coastal Biocare · Aug 2006
SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
K061500 · Sic Invent AG · Aug 2006
SFB & CFB IMPLANTS
K061003 · Nobel Biocare AB · Jun 2006
K061176 · STRAUMANN DENTAL IMPLANTS
Download PDF FDA Summary Institut Straumann AG