I-FIX SYSTEM

Implant, Endosseous, Root-form

DENTIS CO. LTD.

The following data is part of a premarket notification filed by Dentis Co. Ltd. with the FDA for I-fix System.

Pre-market Notification Details

• Device ID: K083586
• 510k Number: K083586
• Device Name: I-FIX SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: DENTIS CO. LTD. 13340 E FIRESTONE BLVD SUITE J Santa Fe Springs, CA 90670
• Contact: Jung Bae Bang
• Correspondent: Jung Bae Bang; DENTIS CO. LTD. 13340 E FIRESTONE BLVD SUITE J Santa Fe Springs, CA 90670
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-04
• Decision Date: 2009-04-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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