CERABIEN MiLai

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 Cerabien Milai.

Pre-market Notification Details

• Device ID: K213147
• 510k Number: K213147
• Device Name: CERABIEN MiLai
• Classification: Powder, Porcelain
• Applicant: Kuraray Noritake Dental Inc. Tokiwabashi Tower, 2-6-4, Otemachi Chiyoda-ku, JP 100-0004
• Contact: Yasujiro Ohara
• Correspondent: Yasujiro Ohara; Kuraray Noritake Dental Inc. Tokiwabashi Tower, 2-6-4, Otemachi Chiyoda-ku, JP 100-0004
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-27
• Decision Date: 2022-03-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EKUR1090010KA0	K213147	000
EKUR1090171KA0	K213147	000
EKUR1090181KA0	K213147	000
EKUR1090191KA0	K213147	000
EKUR1090201KA0	K213147	000
EKUR1090212KA0	K213147	000
EKUR1090222KA0	K213147	000
EKUR1090232KA0	K213147	000
EKUR1090242KA0	K213147	000
EKUR1090252KA0	K213147	000
EKUR1090262KA0	K213147	000
EKUR1090161KA0	K213147	000
EKUR1090151KA0	K213147	000
EKUR1090141KA0	K213147	000
EKUR1090020KA0	K213147	000
EKUR1090051KA0	K213147	000
EKUR1090061KA0	K213147	000
EKUR1090071KA0	K213147	000
EKUR1090081KA0	K213147	000
EKUR1090091KA0	K213147	000
EKUR1090101KA0	K213147	000
EKUR1090111KA0	K213147	000
EKUR1090121KA0	K213147	000
EKUR1090131KA0	K213147	000
EKUR1090272KA0	K213147	000
EKUR1090282KA0	K213147	000
EKUR1090421KA0	K213147	000
EKUR1090431KA0	K213147	000
EKUR1090441KA0	K213147	000
EKUR1090451KA0	K213147	000
EKUR1090461KA0	K213147	000
EKUR1090471KA0	K213147	000
EKUR1090481KA0	K213147	000
EKUR1090491KA0	K213147	000
EKUR1090501KA0	K213147	000
EKUR1090511KA0	K213147	000
EKUR1090411KA0	K213147	000
EKUR1090401KA0	K213147	000
EKUR1090391KA0	K213147	000
EKUR1090292KA0	K213147	000
EKUR1090302KA0	K213147	000
EKUR1090312KA0	K213147	000
EKUR1090322KA0	K213147	000
EKUR1090332KA0	K213147	000
EKUR1090342KA0	K213147	000
EKUR1090352KA0	K213147	000
EKUR1090362KA0	K213147	000
EKUR1090371KA0	K213147	000
EKUR1090381KA0	K213147	000
EKUR2112599KA0	K213147	000