Cleared Special

K071585 - P.004 HEALING ABUTMENTS AND CLOSURE SCREWS
(FDA 510(k) Clearance)

K071585 · Straumann USA · Dental

Jul 2007

Decision

30d

Days

Class 2

Risk

K071585 is an FDA 510(k) clearance for the P.004 HEALING ABUTMENTS AND CLOSURE SCREWS. 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 July 11, 2007, 30 days after receiving the submission on June 11, 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	K071585 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2007
Decision Date	July 11, 2007
Days to Decision	30 days
Submission Type	Special
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.