P.0004 IMPLANTS

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 P.0004 Implants.

Pre-market Notification Details

• Device ID: K062129
• 510k Number: K062129
• Device Name: P.0004 IMPLANTS
• Classification: Implant, Endosseous, Root-form
• Applicant: INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810
• Contact: Elaine Alan
• Correspondent: Elaine Alan; INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-26
• Decision Date: 2006-10-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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