DIO PROTEM IMPLANT SYSTEM

Implant, Endosseous, Root-form

DIO DEPARTMENT DSI, INC.

The following data is part of a premarket notification filed by Dio Department Dsi, Inc. with the FDA for Dio Protem Implant System.

Pre-market Notification Details

• Device ID: K080126
• 510k Number: K080126
• Device Name: DIO PROTEM IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: DIO DEPARTMENT DSI, INC. 3540 WILSHIRE BLVD. SUITE 1104 Los Angeles, CA 90010
• Contact: Hyungick Kim
• Correspondent: Hyungick Kim; DIO DEPARTMENT DSI, INC. 3540 WILSHIRE BLVD. SUITE 1104 Los Angeles, CA 90010
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-01-17
• Decision Date: 2008-04-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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