BRANEMARK SYSTEM STANDARD 3.75MM FIXTURE

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 Standard 3.75mm Fixture.

Pre-market Notification Details

• Device ID: K925765
• 510k Number: K925765
• Device Name: BRANEMARK SYSTEM STANDARD 3.75MM FIXTURE
• Classification: Implant, Endosseous, Root-form
• Applicant: NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago, IL 60632
• Contact: Thomas L Parker
• Correspondent: Thomas L Parker; NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago, IL 60632
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-11-13
• Decision Date: 1993-10-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07332747014815	K925765	000
07332747159394	K925765	000
07332747159387	K925765	000
07332747159370	K925765	000