The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios S with the FDA for Neodent Implant System.
Device ID | K101945 |
510k Number | K101945 |
Device Name: | NEODENT IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
Contact | Linda K Schulz |
Correspondent | Linda K Schulz JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 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 | 2010-07-12 |
Decision Date | 2011-01-26 |
Summary: | summary |