Cleared Traditional

K072151 - P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
(FDA 510(k) Clearance)

K072151 · Straumann USA · Dental

Sep 2007

Decision

39d

Days

Class 2

Risk

K072151 is an FDA 510(k) clearance for the P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS. 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 September 11, 2007, 39 days after receiving the submission on August 3, 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	K072151 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2007
Decision Date	September 11, 2007
Days to Decision	39 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.