Cleared Special

K072497 - P.004 NC GOLD ABUTMENT FOR CROWNS

K072497 is an FDA 510(k) clearance for P.004 NC GOLD ABUTMENT FOR CROWNS, 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 21-day FDA review.

K072497 · Institut Straumann AG · Dental device
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Sep 2007
Decision
21d
Days
Class 2
Risk

K072497 is an FDA 510(k) clearance for the P.004 NC GOLD ABUTMENT FOR CROWNS. 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 September 26, 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

FDA 510(k) Submission Details - K072497

510(k) Number K072497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2007
Decision Date September 26, 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.

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 649
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K072497.
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