NOBELSPEEDY IMPLANTS

Implant, Endosseous, Root-form

NOBEL BIOCARE AB

The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelspeedy Implants.

Pre-market Notification Details

• Device ID: K050406
• 510k Number: K050406
• Device Name: NOBELSPEEDY IMPLANTS
• Classification: Implant, Endosseous, Root-form
• Applicant: NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887
• Contact: Elizabeth J Mason
• Correspondent: Elizabeth J Mason; NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-02-17
• Decision Date: 2005-06-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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