Kontact Dental Implant System

Implant, Endosseous, Root-form

Biotech Dental, SAS

The following data is part of a premarket notification filed by Biotech Dental, Sas with the FDA for Kontact Dental Implant System.

Pre-market Notification Details

• Device ID: K213997
• 510k Number: K213997
• Device Name: Kontact Dental Implant System
• Classification: Implant, Endosseous, Root-form
• Applicant: Biotech Dental, SAS 305, Allées De Craponne Salon De Provence, FR 13300
• Contact: Delphine Mercier
• Correspondent: Chris Brown; Aclivi, LLC 3250 Brackley Drive Ann Arbor, MI 48105
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-12-21
• Decision Date: 2022-07-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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