Cleared Traditional

K071888 - STRAUMANN P.004 RC GOLD ABUTMENT FOR BR...

K071888 is the FDA 510(k) clearance for STRAUMANN P.004 RC GOLD ABUTMENT FOR BR... by Straumann USA. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K071888 · Straumann USA · Dental device
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Oct 2007
Decision
98d
Days
Class 2
Risk

K071888 is an FDA 510(k) clearance for the STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES. 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 October 15, 2007 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K071888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2007
Decision Date October 15, 2007
Days to Decision 98 days
Submission Type Traditional
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
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
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