Implantswiss Dental Implant System And Implantswiss Dental Abutment System

Implant, Endosseous, Root-form

Novodent SA

The following data is part of a premarket notification filed by Novodent Sa with the FDA for Implantswiss Dental Implant System And Implantswiss Dental Abutment System.

Pre-market Notification Details

• Device ID: K200867
• 510k Number: K200867
• Device Name: Implantswiss Dental Implant System And Implantswiss Dental Abutment System
• Classification: Implant, Endosseous, Root-form
• Applicant: Novodent SA Y-PARC Technopole Avenue Des Sciences 11 Yverdons-les-bains, CH Ch1400
• Contact: Cem Kocer
• Correspondent: H. Semih Oktay; CardioMed Device Consultants, LLC 1783 Forest Drive #254 Annapolis, MD 21401
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-01
• Decision Date: 2020-04-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630188206739	K200867	000
07640168181086	K200867	000
07640168181260	K200867	000
07640168181277	K200867	000
07640168181284	K200867	000
07640168181291	K200867	000
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07640168181635	K200867	000
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07640168182199	K200867	000
07640168182205	K200867	000
07640168182212	K200867	000
07640168189204	K200867	000
07640168189211	K200867	000
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07640168189242	K200867	000
07640168181079	K200867	000
07640168180959	K200867	000
07630188206746	K200867	000
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07640168181093	K200867	000
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07640168180508	K200867	000
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07640168180539	K200867	000
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07640168180553	K200867	000
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07640168182335	K200867	000