The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios Sa with the FDA for Neodent Implant System - Titanium Base For Cerec.
| Device ID | K160964 |
| 510k Number | K160964 |
| Device Name: | Neodent Implant System - Titanium Base For CEREC |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA AV. JUSCELINO KUBITSCHEK DE OLIVEIRA, 3291 - CIC Curitiba, BR 81270-200 |
| Contact | Jacson Cambruzzi |
| Correspondent | Jennifer Jackson STRAUMANN USA, LLC 60-100 MINUTEMAN RD Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-06 |
| Decision Date | 2016-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878018636 | K160964 | 000 |
| 07899878018629 | K160964 | 000 |
| 07899878018612 | K160964 | 000 |
| 07899878018605 | K160964 | 000 |
| 07899878018599 | K160964 | 000 |
| 07899878018582 | K160964 | 000 |
| 07899878018575 | K160964 | 000 |