CERANA

Powder, Porcelain

NORDISKA DENTAL AB

The following data is part of a premarket notification filed by Nordiska Dental Ab with the FDA for Cerana.

Pre-market Notification Details

• Device ID: K992161
• 510k Number: K992161
• Device Name: CERANA
• Classification: Powder, Porcelain
• Applicant: NORDISKA DENTAL AB 1205 DE LA VINA Santa Barbara, CA 93101
• Contact: Christine Emanuel
• Correspondent: Christine Emanuel; NORDISKA DENTAL AB 1205 DE LA VINA Santa Barbara, CA 93101
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-06-25
• Decision Date: 1999-09-22
• Summary: summary