Straumann® Dental Implant System ¿ Roxolid® SLA Implants

Implant, Endosseous, Root-form

STRAUMANN USA, LLC

The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann® Dental Implant System ¿ Roxolid® Sla Implants.

Pre-market Notification Details

• Device ID: K150938
• 510k Number: K150938
• Device Name: Straumann® Dental Implant System ¿ Roxolid® SLA Implants
• Classification: Implant, Endosseous, Root-form
• 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: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-07
• Decision Date: 2015-07-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630031706539	K150938	000
07630031718495	K150938	000
07630031718488	K150938	000
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