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 | K141777 |
| 510k Number | K141777 |
| Device Name: | NEODENT IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 12264 EL CAMINO REAL, STE 400 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 12264 EL CAMINO REAL, STE 400 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 | 2014-07-02 |
| Decision Date | 2015-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878006879 | K141777 | 000 |
| 07899878006862 | K141777 | 000 |
| 07899878006374 | K141777 | 000 |
| 07899878006367 | K141777 | 000 |
| 07899878006350 | K141777 | 000 |
| 07899878005513 | K141777 | 000 |
| 07899878005506 | K141777 | 000 |
| 07899878005490 | K141777 | 000 |