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 | K133696 |
| 510k Number | K133696 |
| Device Name: | NEODENT IMPLANT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-03 |
| Decision Date | 2014-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878005193 | K133696 | 000 |
| 07898237561127 | K133696 | 000 |
| 07898237561134 | K133696 | 000 |
| 07898237561141 | K133696 | 000 |
| 07898237561158 | K133696 | 000 |
| 07899878005100 | K133696 | 000 |
| 07899878005117 | K133696 | 000 |
| 07899878005124 | K133696 | 000 |
| 07899878005131 | K133696 | 000 |
| 07899878005148 | K133696 | 000 |
| 07899878005155 | K133696 | 000 |
| 07899878005162 | K133696 | 000 |
| 07899878005179 | K133696 | 000 |
| 07899878005186 | K133696 | 000 |
| 07898237561110 | K133696 | 000 |