REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH

Denture, Plastic, Teeth

UNION DENTAL S.A./UNIDESA.ODI

The following data is part of a premarket notification filed by Union Dental S.a./unidesa.odi with the FDA for Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic Teeth.

Pre-market Notification Details

Device IDK070591
510k NumberK070591
Device Name:REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH
ClassificationDenture, Plastic, Teeth
Applicant UNION DENTAL S.A./UNIDESA.ODI PASEO DE LA ESTACION, 4 Tielmes, Madrid,  ES 28550
ContactJose Luis Rodriguez
CorrespondentJose Luis Rodriguez
UNION DENTAL S.A./UNIDESA.ODI PASEO DE LA ESTACION, 4 Tielmes, Madrid,  ES 28550
Product CodeELM  
CFR Regulation Number872.3590 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-01
Decision Date2007-05-11
Summary:summary

NIH GUDID Devices

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