Cleared Special

K080286 - CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS
(FDA 510(k) Clearance)

K080286 · Straumann USA · Dental

Mar 2008

Decision

32d

Days

Class 2

Risk

K080286 is an FDA 510(k) clearance for the CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS. 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 March 7, 2008, 32 days after receiving the submission on February 4, 2008.

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	K080286 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2008
Decision Date	March 07, 2008
Days to Decision	32 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.