Cleared Special

K061176 - STRAUMANN DENTAL IMPLANTS

K061176 is the FDA 510(k) clearance for STRAUMANN DENTAL IMPLANTS by Institut Straumann AG. It is a Class 2 Dental device (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)
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.

View all Institut Straumann AG devices

Submission Details

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
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 611
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K061176.
ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED
K061717 · Zimmer Dental, Inc. · Sep 2006
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16
K062281 · Zimmer Dental, Inc. · Sep 2006
STRAUMANN NARROW NECK IMPLANTS
K060958 · Straumann USA · Aug 2006
SFB & CFB IMPLANTS
K061003 · Nobel Biocare AB · Jun 2006
SLACTIVE IMPLANTS
K053088 · Institut Straumann AG · Feb 2006
ZIMMER DENTAL ONE-PIECE IMPLANT
K052997 · Zimmer Dental, Inc. · Jan 2006