Cleared Special

K072679 - P.004 ABUTMENTS

K072679 is the FDA 510(k) clearance for P.004 ABUTMENTS by Institut Straumann AG. It is a Class 2 Dental device (product code NHA) cleared through the Special 510(k) pathway after a 21-day FDA review.

K072679 · Institut Straumann AG · Dental device
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Oct 2007
Decision
21d
Days
Class 2
Risk

K072679 is an FDA 510(k) clearance for the P.004 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 October 12, 2007 after a review of 21 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 K072679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2007
Decision Date October 12, 2007
Days to Decision 21 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
106d faster than avg
Panel avg: 127d · This submission: 21d
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 K072679.
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STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES
K071888 · Straumann USA · Oct 2007
P.004 NC ANATOMIC ABUTMENTS
K071357 · Institut Straumann AG · Sep 2007
P.004 NC GOLD ABUTMENT FOR CROWNS
K072497 · Institut Straumann AG · Sep 2007
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
K072151 · Straumann USA · Sep 2007