Cleared Special

K052272 - STRAUMANN COMPUTER AIDED RESTORATION SERVICE
(FDA 510(k) Clearance)

K052272 · Straumann USA · Dental

Jan 2006

Decision

134d

Days

Class 2

Risk

K052272 is an FDA 510(k) clearance for the STRAUMANN COMPUTER AIDED RESTORATION SERVICE. 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 3, 2006, 134 days after receiving the submission on August 22, 2005.

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	K052272 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 2005
Decision Date	January 03, 2006
Days to Decision	134 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.