Estelite Universal Flow

Material, Tooth Shade, Resin

Tokuyama Dental Corporation

The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Estelite Universal Flow.

Pre-market Notification Details

• Device ID: K180613
• 510k Number: K180613
• Device Name: Estelite Universal Flow
• Classification: Material, Tooth Shade, Resin
• Applicant: Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo, JP 110-0016
• Contact: Keith A. Barritt
• Correspondent: Keith A. Barritt; Fish & Richardson P.C. 1000 Maine Ave., S.W., Suite 1000 Washington, DC 20024
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-03-08
• Decision Date: 2018-07-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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