ZIRPRIME

Powder, Porcelain

NORITAKE CO., INC.

The following data is part of a premarket notification filed by Noritake Co., Inc. with the FDA for Zirprime.

Pre-market Notification Details

• Device ID: K111383
• 510k Number: K111383
• Device Name: ZIRPRIME
• Classification: Powder, Porcelain
• Applicant: NORITAKE CO., INC. 700 12 STREET, N.W., SUITE 1100 Washington, DC 20005
• Contact: Ivan Wasserman
• Correspondent: Ivan Wasserman; NORITAKE CO., INC. 700 12 STREET, N.W., SUITE 1100 Washington, DC 20005
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-05-17
• Decision Date: 2011-08-12