BRANEMARK SYSTEM TITANIUM COVER SCREWS

Implant, Endosseous, Root-form

NOBELPHARMA USA, INC.

The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Branemark System Titanium Cover Screws.

Pre-market Notification Details

• Device ID: K925771
• 510k Number: K925771
• Device Name: BRANEMARK SYSTEM TITANIUM COVER SCREWS
• Classification: Implant, Endosseous, Root-form
• Applicant: NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606
• Contact: Thomas J Muldoon
• Correspondent: Thomas J Muldoon; NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-11-16
• Decision Date: 1993-04-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07332747003239	K925771	000
07332747003222	K925771	000
07332747003215	K925771	000