ITI DISTANCE SYSTEM

Implant, Endosseous, Root-form

THE STRAUMANN CO.

The following data is part of a premarket notification filed by The Straumann Co. with the FDA for Iti Distance System.

Pre-market Notification Details

• Device ID: K931993
• 510k Number: K931993
• Device Name: ITI DISTANCE SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: THE STRAUMANN CO. ONE ALEWIFE CENTER Cambridge, MA 02140 -2317
• Contact: Carolyn Bitetti
• Correspondent: Carolyn Bitetti; THE STRAUMANN CO. ONE ALEWIFE CENTER Cambridge, MA 02140 -2317
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-04-23
• Decision Date: 1994-04-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630031724588	K931993	000