BRANEMARK SYSTEM 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 Self-tapping Fixture.

Pre-market Notification Details

• Device ID: K925762
• 510k Number: K925762
• Device Name: BRANEMARK SYSTEM SELF-TAPPING FIXTURE
• Classification: Implant, Endosseous, Root-form
• Applicant: NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606
• Contact: Thomas L Parker
• Correspondent: Thomas L Parker; 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: 1992-11-13
• Decision Date: 1993-10-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07332747159400	K925762	000
07332747000870	K925762	000
07332747000887	K925762	000
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07332747159431	K925762	000
07332747159448	K925762	000
07332747159455	K925762	000
07332747159462	K925762	000
07332747159479	K925762	000
07332747159486	K925762	000
07332747159493	K925762	000
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07332747004656	K925762	000
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07332747004694	K925762	000
07332747004700	K925762	000
07332747004717	K925762	000
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07332747004632	K925762	000
07332747001211	K925762	000
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07332747001204	K925762	000
07332747004731	K925762	000