Spiral Shape Dental Implant System

Implant, Endosseous, Root-form

GP Implants

The following data is part of a premarket notification filed by Gp Implants with the FDA for Spiral Shape Dental Implant System.

Pre-market Notification Details

• Device ID: K162299
• 510k Number: K162299
• Device Name: Spiral Shape Dental Implant System
• Classification: Implant, Endosseous, Root-form
• Applicant: GP Implants Beeri 12A Ap7 Netanya, IL
• Contact: Pivovarov German
• Correspondent: Angela Blackwell; Blackwell Device Consulting P.O. Box 5845 Statesville, NC 28687 -5845
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-16
• Decision Date: 2017-06-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290018068021	K162299	000
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