SCREW-VENT DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

SULZER DENTAL, INC.

The following data is part of a premarket notification filed by Sulzer Dental, Inc. with the FDA for Screw-vent Dental Implant System.

Pre-market Notification Details

• Device ID: K011028
• 510k Number: K011028
• Device Name: SCREW-VENT DENTAL IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: SULZER DENTAL, INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308
• Contact: Diana Smith
• Correspondent: Diana Smith; SULZER DENTAL, INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-04-05
• Decision Date: 2001-05-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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