Llis, Vittra APS

Material, Tooth Shade, Resin

Dentscare LTDA

The following data is part of a premarket notification filed by Dentscare Ltda with the FDA for Llis, Vittra Aps.

Pre-market Notification Details

• Device ID: K191306
• 510k Number: K191306
• Device Name: Llis, Vittra APS
• Classification: Material, Tooth Shade, Resin
• Applicant: Dentscare LTDA Av. Edgar Nelson Meister, 474 Joinville, BR 89219-501
• Contact: Roberta Uyara
• Correspondent: Rodrigo Abreu; United Regulatory LLC 12343 NW 25th St Coral Springs, FL 33065
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-14
• Decision Date: 2019-12-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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