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 - Cm Pro Peek Abutment.
| Device ID | K170080 |
| 510k Number | K170080 |
| Device Name: | Neodent Implant System - CM Pro PEEK Abutment |
| 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 | Julianne Lechechem |
| 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 | 2017-01-10 |
| Decision Date | 2017-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878023043 | K170080 | 000 |
| 07899878047735 | K170080 | 000 |
| 07899878047728 | K170080 | 000 |
| 07899878047711 | K170080 | 000 |
| 07899878047704 | K170080 | 000 |
| 07899878047698 | K170080 | 000 |
| 07899878047681 | K170080 | 000 |
| 07899878047674 | K170080 | 000 |
| 07899878047667 | K170080 | 000 |
| 07899878047650 | K170080 | 000 |
| 07899878047643 | K170080 | 000 |
| 07899878047742 | K170080 | 000 |
| 07899878022930 | K170080 | 000 |
| 07899878023036 | K170080 | 000 |
| 07899878023029 | K170080 | 000 |
| 07899878023012 | K170080 | 000 |
| 07899878023005 | K170080 | 000 |
| 07899878022992 | K170080 | 000 |
| 07899878022985 | K170080 | 000 |
| 07899878022978 | K170080 | 000 |
| 07899878022961 | K170080 | 000 |
| 07899878022954 | K170080 | 000 |
| 07899878022947 | K170080 | 000 |
| 07899878047636 | K170080 | 000 |