REPLACE TIUNITE ENDOSSEOUS IMPLANT

Implant, Endosseous, Root-form

NOBEL BIOCARE UAS INC

The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Replace Tiunite Endosseous Implant.

Pre-market Notification Details

• Device ID: K023113
• 510k Number: K023113
• Device Name: REPLACE TIUNITE ENDOSSEOUS IMPLANT
• Classification: Implant, Endosseous, Root-form
• Applicant: NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887
• Contact: Herbert Crane
• Correspondent: Herbert Crane; NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. 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: 2002-09-19
• Decision Date: 2002-09-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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