SM INTERNAL./EXTERNAL 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 Sm Internal./external Implant System.

Pre-market Notification Details

• Device ID: K070569
• 510k Number: K070569
• Device Name: SM INTERNAL./EXTERNAL IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: DIO DEPARTMENT DSI, INC. 13340 E. FIRESTONE BLVD SUITE J Santa Fe Springs, CA 90670
• Contact: Kenny Lim
• Correspondent: Kenny Lim; DIO DEPARTMENT DSI, INC. 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: 2007-02-28
• Decision Date: 2007-11-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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