MIS Internal Hex Dental Implant System

Implant, Endosseous, Root-form

MIS Implants Technologies Ltd.

The following data is part of a premarket notification filed by Mis Implants Technologies Ltd. with the FDA for Mis Internal Hex Dental Implant System.

Pre-market Notification Details

• Device ID: K180282
• 510k Number: K180282
• Device Name: MIS Internal Hex Dental Implant System
• Classification: Implant, Endosseous, Root-form
• Applicant: MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park Bar Lev Industrial Park, IL 2015600
• Contact: Arbel Shezaf
• Correspondent: Randy Prebula; Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-01-31
• Decision Date: 2018-06-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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