NOBELREPLACE HEXAGONAL IMPLANT

Implant, Endosseous, Root-form

NOBEL BIOCARE USA LLC

The following data is part of a premarket notification filed by Nobel Biocare Usa Llc with the FDA for Nobelreplace Hexagonal Implant.

Pre-market Notification Details

• Device ID: K073142
• 510k Number: K073142
• Device Name: NOBELREPLACE HEXAGONAL IMPLANT
• Classification: Implant, Endosseous, Root-form
• Applicant: NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887
• Contact: Kam Leung
• Correspondent: Kam Leung; NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-11-07
• Decision Date: 2008-01-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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