Cleared Special

K071585 - P.004 HEALING ABUTMENTS AND CLOSURE SCREWS

K071585 is the FDA 510(k) clearance for P.004 HEALING ABUTMENTS AND CLOSURE SCREWS by Straumann USA. It is a Class 2 Dental device (product code NHA) cleared through the Special 510(k) pathway after a 30-day FDA review.

K071585 · Straumann USA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
30d
Days
Class 2
Risk

K071585 is an FDA 510(k) clearance for the P.004 HEALING ABUTMENTS AND CLOSURE SCREWS. 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 Straumann USA (Andover, US). The FDA issued a Cleared decision on July 11, 2007 after a review of 30 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 Straumann USA devices

Submission Details

510(k) Number K071585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2007
Decision Date July 11, 2007
Days to Decision 30 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
97d faster than avg
Panel avg: 127d · This submission: 30d
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 480
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K071585.
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
K072151 · Straumann USA · Sep 2007
STRAUMANN P.004 RC GOLD ABUTMENT
K070549 · Institut Straumann AG · Aug 2007
STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS
K072071 · Institut Straumann AG · Aug 2007
NARROW NECK TEMPORARY COPING
K070744 · Institut Straumann AG · Jun 2007
TITANIUM SCALLOPED ABUTMENT
K063768 · Vident · Jun 2007
WN SYNOCTA GOLD ABUTMENT
K063789 · Straumann USA · May 2007