Cleared Traditional

Straumann TLX Implant System

K200586 · Institut Straumann AG · Dental
Aug 2020
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K200586 is an FDA 510(k) clearance for the Straumann TLX Implant System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on August 20, 2020, 167 days after receiving the submission on March 6, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K200586 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2020
Decision Date August 20, 2020
Days to Decision 167 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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