Cleared Special

K063789 - WN SYNOCTA GOLD ABUTMENT
(FDA 510(k) Clearance)

K063789 · Straumann USA · Dental

May 2007

Decision

140d

Days

Class 2

Risk

K063789 is an FDA 510(k) clearance for the WN SYNOCTA GOLD ABUTMENT. 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 May 10, 2007, 140 days after receiving the submission on December 21, 2006.

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	K063789 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2006
Decision Date	May 10, 2007
Days to Decision	140 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.