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 |