The following data is part of a premarket notification filed by Sin Sistema De Implante Nacional Ltda with the FDA for Sistema De Implante Nacional (s.i.n.); Dental Implant System.
Device ID | K051859 |
510k Number | K051859 |
Device Name: | SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | SIN SISTEMA DE IMPLANTE NACIONAL LTDA 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
Contact | Floyd G Larson |
Correspondent | Floyd G Larson SIN SISTEMA DE IMPLANTE NACIONAL LTDA 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-08 |
Decision Date | 2005-09-23 |
Summary: | summary |