Cleared Traditional

ANKYLOS DENTAL IMPLANT SYSTEM

K041509 · Friadent GmbH · Dental
Aug 2004
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K041509 is an FDA 510(k) clearance for the ANKYLOS DENTAL IMPLANT SYSTEM, 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 26, 2004, 80 days after receiving the submission on June 7, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K041509 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2004
Decision Date August 26, 2004
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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