ENDOSSEOUS DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

SOUTHERN IMPLANTS, INC.

The following data is part of a premarket notification filed by Southern Implants, Inc. with the FDA for Endosseous Dental Implant System.

Pre-market Notification Details

• Device ID: K071161
• 510k Number: K071161
• Device Name: ENDOSSEOUS DENTAL IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: SOUTHERN IMPLANTS, INC. 10355 B DEMOCRACY LANE Fairfax, VA 22030
• Contact: Greta M Hols
• Correspondent: Greta M Hols; SOUTHERN IMPLANTS, INC. 10355 B DEMOCRACY LANE Fairfax, VA 22030
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-04-26
• Decision Date: 2007-11-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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