Cleared Special

K081005 - P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS

K081005 is an FDA 510(k) clearance for P.004 NC CARES TITANIUM AND CERAMIC ABU..., manufactured by Institut Straumann AG. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 24-day FDA review.

K081005 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
24d
Days
Class 2
Risk

K081005 is an FDA 510(k) clearance for the P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS. 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 May 2, 2008 after a review of 24 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.

FDA 510(k) Submission Details - K081005

510(k) Number K081005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2008
Decision Date May 02, 2008
Days to Decision 24 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
104d faster than avg
Panel avg: 128d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

NHA Device Classification - Class 2, Special Controls

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 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K081005.
MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS
K080598 · Intra-Lock International · May 2008
INCLUSIVE IMPLANT ABUTMENTS
K073217 · Inclusive Dental Solutions · May 2008
AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM
K080397 · American Dental Implant Corporation · May 2008
P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS
K080239 · Straumann Manufacturing, Inc. · Apr 2008
FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS
K072730 · Dentsply Intl. · Mar 2008
CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT
K073345 · Biomet 3i, Inc. · Mar 2008
K081005 · P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS
Download PDF FDA Summary Institut Straumann AG