Cleared Traditional

K070549 - STRAUMANN P.004 RC GOLD ABUTMENT

K070549 is the FDA 510(k) clearance for STRAUMANN P.004 RC GOLD ABUTMENT by Institut Straumann AG. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K070549 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
186d
Days
Class 2
Risk

K070549 is an FDA 510(k) clearance for the STRAUMANN P.004 RC GOLD ABUTMENT. 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 August 31, 2007 after a review of 186 days - an extended review cycle.

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.

View all Institut Straumann AG devices

Submission Details

510(k) Number K070549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2007
Decision Date August 31, 2007
Days to Decision 186 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
59d slower than avg
Panel avg: 127d · This submission: 186d
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 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K070549.
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
STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS
K072071 · Institut Straumann AG · Aug 2007
P.004 HEALING ABUTMENTS AND CLOSURE SCREWS
K071585 · Straumann USA · Jul 2007
NARROW NECK TEMPORARY COPING
K070744 · Institut Straumann AG · Jun 2007