Straumann TLX Implant System

Implant, Endosseous, Root-form

Institut Straumann AG

The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Tlx Implant System.

Pre-market Notification Details

• Device ID: K200586
• 510k Number: K200586
• Device Name: Straumann TLX Implant System
• Classification: Implant, Endosseous, Root-form
• Applicant: Institut Straumann AG Peter Merian Weg 12 Basel, CH 4002
• Contact: Renate Reiss
• Correspondent: Jennifer M Jackson; Straumann USA, LLC 60 Minuteman Road Andover, MA 01810
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-06
• Decision Date: 2020-08-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630031751102	K200586	000
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