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 | K150199 |
| 510k Number | K150199 |
| Device Name: | Neodent Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S AVE JUSCELINO KUBITSCHEK DE OLIVEIRA 3291-CIC Curitiba, BR 81270 |
| Contact | Jacson Cambruzzi |
| Correspondent | Kevin A Thomas PaxMed International, LLC 12264 El Camino Real, Suite 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 | 2015-01-29 |
| Decision Date | 2015-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878004998 | K150199 | 000 |
| 07899878004899 | K150199 | 000 |
| 07899878004905 | K150199 | 000 |
| 07899878004912 | K150199 | 000 |
| 07899878004929 | K150199 | 000 |
| 07899878004936 | K150199 | 000 |
| 07899878004943 | K150199 | 000 |
| 07899878004950 | K150199 | 000 |
| 07899878004967 | K150199 | 000 |
| 07899878004974 | K150199 | 000 |
| 07899878004981 | K150199 | 000 |
| 07899878004882 | K150199 | 000 |