BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL

Implant, Endosseous, Root-form

BIODENTA SWISS AG

The following data is part of a premarket notification filed by Biodenta Swiss Ag with the FDA for Biodenta Dental Implant System - Bone Level.

Pre-market Notification Details

• Device ID: K111003
• 510k Number: K111003
• Device Name: BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL
• Classification: Implant, Endosseous, Root-form
• Applicant: BIODENTA SWISS AG TRAMSTRASSE 16 Berneck, St. Gallen, CH 9442
• Contact: David Eiler
• Correspondent: David Eiler; BIODENTA SWISS AG TRAMSTRASSE 16 Berneck, St. Gallen, CH 9442
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-04-11
• Decision Date: 2011-09-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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