NobelProcera HT ML FCZ Bridge

Teeth, Porcelain

Nobel Biocare AB

The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelprocera Ht Ml Fcz Bridge.

Pre-market Notification Details

• Device ID: K162043
• 510k Number: K162043
• Device Name: NobelProcera HT ML FCZ Bridge
• Classification: Teeth, Porcelain
• Applicant: Nobel Biocare AB BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteborg, SE Se-411 17
• Contact: Charlemagne Chua
• Correspondent: Charlemagne Chua; Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
• Product Code: ELL
• CFR Regulation Number: 872.3920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-07-25
• Decision Date: 2016-11-22
• Summary: summary

NIH GUDID Devices

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