AMBARINO High-Class

Material, Tooth Shade, Resin

Creamed GmbH & Co. Produktions- Und Handels KG

The following data is part of a premarket notification filed by Creamed Gmbh & Co. Produktions- Und Handels Kg with the FDA for Ambarino High-class.

Pre-market Notification Details

Device IDK222723
510k NumberK222723
Device Name:AMBARINO High-Class
ClassificationMaterial, Tooth Shade, Resin
Applicant Creamed GmbH & Co. Produktions- Und Handels KG Tom-Mutters-Str. 4a Marburg,  DE 35041
ContactRobert Lemmer
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-09-08
Decision Date2022-09-09

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