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
07630031743176	K200586	000
07630031742902	K200586	000
07630031742896	K200586	000
07630031742889	K200586	000
07630031742872	K200586	000
07630031742865	K200586	000
07630031742858	K200586	000
07630031742841	K200586	000
07630031742834	K200586	000
07630031742605	K200586	000
07630031742919	K200586	000
07630031742926	K200586	000
07630031742933	K200586	000
07630031743169	K200586	000
07630031743152	K200586	000
07630031743145	K200586	000
07630031743138	K200586	000
07630031743121	K200586	000
07630031743114	K200586	000
07630031742964	K200586	000
07630031742957	K200586	000
07630031742940	K200586	000
07630031742599	K200586	000
07630031742582	K200586	000
07630031742315	K200586	000
07630031742308	K200586	000
07630031742292	K200586	000
07630031742261	K200586	000
07630031742285	K200586	000
07630031742278	K200586	000
07630031752697	K200586	000
07630031752680	K200586	000
07630031746115	K200586	000
07630031742322	K200586	000
07630031742339	K200586	000
07630031742346	K200586	000
07630031742575	K200586	000
07630031742568	K200586	000
07630031742551	K200586	000
07630031742544	K200586	000
07630031742391	K200586	000
07630031742384	K200586	000
07630031742377	K200586	000
07630031742360	K200586	000
07630031742353	K200586	000
07630031746092	K200586	000
07630031747259	K200586	000
07630031751553	K200586	000
07630031751546	K200586	000
07630031751539	K200586	000
07630031751522	K200586	000
07630031751515	K200586	000
07630031751508	K200586	000
07630031751492	K200586	000
07630031751485	K200586	000
07630031751478	K200586	000
07630031751560	K200586	000
07630031751577	K200586	000
07630031751584	K200586	000
07630031747242	K200586	000
07630031746221	K200586	000
07630031746214	K200586	000
07630031751645	K200586	000
07630031751638	K200586	000
07630031751621	K200586	000
07630031751614	K200586	000
07630031751607	K200586	000
07630031751591	K200586	000
07630031751461	K200586	000
07630031751454	K200586	000
07630031751188	K200586	000
07630031751171	K200586	000
07630031751164	K200586	000
07630031751157	K200586	000
07630031751140	K200586	000
07630031751133	K200586	000
07630031751126	K200586	000
07630031751119	K200586	000
07630031751102	K200586	000
07630031751195	K200586	000
07630031751201	K200586	000
07630031751218	K200586	000
07630031751447	K200586	000
07630031751430	K200586	000
07630031751423	K200586	000
07630031751416	K200586	000
07630031751409	K200586	000
07630031751393	K200586	000
07630031751386	K200586	000
07630031751379	K200586	000
07630031751225	K200586	000
07630031751096	K200586	000