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.
Device ID | K070591 |
510k Number | K070591 |
Device Name: | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH |
Classification | Denture, Plastic, Teeth |
Applicant | UNION DENTAL S.A./UNIDESA.ODI PASEO DE LA ESTACION, 4 Tielmes, Madrid, ES 28550 |
Contact | Jose Luis Rodriguez |
Correspondent | Jose Luis Rodriguez UNION DENTAL S.A./UNIDESA.ODI PASEO DE LA ESTACION, 4 Tielmes, Madrid, ES 28550 |
Product Code | ELM |
CFR Regulation Number | 872.3590 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-01 |
Decision Date | 2007-05-11 |
Summary: | summary |