ZIRTOUGH

Powder, Porcelain

KURARAY NORITAKE DENTAL INC.

The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Zirtough.

Pre-market Notification Details

• Device ID: K133211
• 510k Number: K133211
• Device Name: ZIRTOUGH
• Classification: Powder, Porcelain
• Applicant: KURARAY NORITAKE DENTAL INC. 700 12TH STREET NW, SUITE 1100 Washington, DC 20005
• Contact: Michio Takigawa
• Correspondent: Michio Takigawa; KURARAY NORITAKE DENTAL INC. 700 12TH STREET NW, 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: 2013-10-18
• Decision Date: 2014-03-20