Cleared Special

K082764 - STRAUMANN WN CARES TITANIUM ABUTMENT

K082764 is the FDA 510(k) clearance for STRAUMANN WN CARES TITANIUM ABUTMENT by Institut Straumann AG. It is a Class 2 Dental device (product code NHA) cleared through the Special 510(k) pathway after a 9-day FDA review.

K082764 · Institut Straumann AG · Dental device
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Oct 2008
Decision
9d
Days
Class 2
Risk

K082764 is an FDA 510(k) clearance for the STRAUMANN WN CARES TITANIUM ABUTMENT. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Institut Straumann AG (Andover, US). The FDA issued a Cleared decision on October 1, 2008 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 Institut Straumann AG devices

Submission Details

510(k) Number K082764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2008
Decision Date October 01, 2008
Days to Decision 9 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
118d faster than avg
Panel avg: 127d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K082764.
ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT
K083474 · Zimmer Dental, Inc. · Dec 2008
ZIOCERA & CONVERTIBLE SYSTEM
K081786 · Osstem Implant Co., Ltd. · Dec 2008
STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS
K082545 · Institut Straumann AG · Oct 2008
ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT
K080164 · Zimmer Dental, Inc. · Sep 2008
HU/HS/HG PROSTHETIC SYSTEM
K081575 · Osstem Implant Co., Ltd. · Sep 2008
CONCAVE RN HEALING CAP
K081186 · Institut Straumann AG · May 2008