Straumann® Retentive System – Novaloc TiN Abutments

Abutment, Implant, Dental, Endosseous

Institut Straumann AG

The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann® Retentive System – Novaloc Tin Abutments.

Pre-market Notification Details

• Device ID: K193046
• 510k Number: K193046
• Device Name: Straumann® Retentive System – Novaloc TiN Abutments
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: Institut Straumann AG Peter Merian Weg 12 Basel, CH Gh-4002
• Contact: Ana C.m. Vianna
• Correspondent: Jennifer M. Jackson; Straumann USA, LLC 60 Minuteman Road Andover, MA 01801
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-11-01
• Decision Date: 2020-08-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630031749727	K193046	000
07630031749871	K193046	000
07630031749888	K193046	000
07630031749895	K193046	000
07630031749901	K193046	000
07630031749918	K193046	000
07630031749925	K193046	000
07630031749932	K193046	000
07630031749949	K193046	000
07630031749956	K193046	000
07630031749963	K193046	000
07630031749970	K193046	000
07630031749864	K193046	000
07630031749857	K193046	000
07630031749840	K193046	000
07630031749734	K193046	000
07630031749741	K193046	000
07630031749758	K193046	000
07630031749765	K193046	000
07630031749772	K193046	000
07630031749789	K193046	000
07630031749796	K193046	000
07630031749802	K193046	000
07630031749819	K193046	000
07630031749826	K193046	000
07630031749833	K193046	000
07630031749987	K193046	000
07630031749994	K193046	000
07630031750006	K193046	000
07630031750211	K193046	000
07630031750327	K193046	000
07630031750334	K193046	000
07630031750341	K193046	000
07630031750358	K193046	000
07630031750365	K193046	000
07630031750372	K193046	000
07630031750389	K193046	000
07630031750396	K193046	000
07630031750402	K193046	000
07630031750419	K193046	000
07630031750204	K193046	000
07630031750198	K193046	000
07630031750181	K193046	000
07630031750013	K193046	000
07630031750020	K193046	000
07630031750037	K193046	000
07630031750105	K193046	000
07630031750112	K193046	000
07630031750129	K193046	000
07630031750136	K193046	000
07630031750143	K193046	000
07630031750150	K193046	000
07630031750167	K193046	000
07630031750174	K193046	000
07630031754806	K193046	000