Cleared Special

K073628 - SYNOCTA ABUTMENTS
(FDA 510(k) Clearance)

K073628 · Straumann USA · Dental

Jan 2008

Decision

27d

Days

Class 2

Risk

K073628 is an FDA 510(k) clearance for the SYNOCTA 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 January 22, 2008, 27 days after receiving the submission on December 26, 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	K073628 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2007
Decision Date	January 22, 2008
Days to Decision	27 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.