SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE

Powder, Porcelain

NORITAKE CO., INC.

The following data is part of a premarket notification filed by Noritake Co., Inc. with the FDA for Super Porcelain Ex-3 Universal Opaque.

Pre-market Notification Details

• Device ID: K111107
• 510k Number: K111107
• Device Name: SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE
• 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: 2011-04-20
• Decision Date: 2011-06-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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