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 | K150367 |
| 510k Number | K150367 |
| Device Name: | Neodent Implant System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S AV. JUSCELINO KUBITSCHEK DE OLIVEIRA, 3291 - CIC Curtiba, BR 81270-200 |
| Contact | Jacson Cambruzzi |
| Correspondent | Kevin A Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 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 | 2015-02-12 |
| Decision Date | 2015-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878018384 | K150367 | 000 |
| 07899878018100 | K150367 | 000 |
| 07899878015512 | K150367 | 000 |
| 07899878015505 | K150367 | 000 |
| 07899878015499 | K150367 | 000 |
| 07899878015482 | K150367 | 000 |
| 07899878015475 | K150367 | 000 |
| 07899878015468 | K150367 | 000 |
| 07899878015437 | K150367 | 000 |
| 07899878018117 | K150367 | 000 |
| 07899878018124 | K150367 | 000 |
| 07899878018131 | K150367 | 000 |
| 07899878018377 | K150367 | 000 |
| 07899878018339 | K150367 | 000 |
| 07899878018322 | K150367 | 000 |
| 07899878018308 | K150367 | 000 |
| 07899878018292 | K150367 | 000 |
| 07899878018285 | K150367 | 000 |
| 07899878018278 | K150367 | 000 |
| 07899878018261 | K150367 | 000 |
| 07899878015420 | K150367 | 000 |