STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES

Abutment, Implant, Dental, Endosseous

STRAUMANN USA, LLC

The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level Screw Retained Bridges.

Pre-market Notification Details

• Device ID: K132844
• 510k Number: K132844
• Device Name: STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810
• Contact: Christopher Klaczyk
• Correspondent: Christopher Klaczyk; STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-11
• Decision Date: 2014-01-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630031702814	K132844	000
07630031750877	K132844	000