BRANEMARK SYSTEM(R) MKII SELF-TAPPING 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(r) Mkii Self-tapping Fixture.

Pre-market Notification Details

• Device ID: K945398
• 510k Number: K945398
• Device Name: BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE
• Classification: Implant, Endosseous, Root-form
• Applicant: NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont, IL 60559
• Contact: Mary Edwards
• Correspondent: Mary Edwards; NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont, IL 60559
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-03
• Decision Date: 1995-04-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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