Cleared Traditional

K071888 - STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES
(FDA 510(k) Clearance)

K071888 · Straumann USA · Dental

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. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA).

Submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on October 15, 2007, 98 days after receiving the submission on July 9, 2007.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3630. To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation..

Submission Details

510(k) Number	K071888 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — 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.