Cleared Special

K032158 - XIVE DENTAL IMPLANT SYSTEM MULTIPLE
(FDA 510(k) Clearance)

K032158 · Friadent GmbH · Dental

Aug 2003

Decision

30d

Days

Class 2

Risk

K032158 is an FDA 510(k) clearance for the XIVE DENTAL IMPLANT SYSTEM MULTIPLE, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Friadent GmbH (Lake Forest, US). The FDA issued a Cleared decision on August 14, 2003, 30 days after receiving the submission on July 15, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K032158 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2003
Decision Date	August 14, 2003
Days to Decision	30 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF