The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios S.a. with the FDA for Neodent Implant System – Gm Line.
| Device ID | K173902 |
| 510k Number | K173902 |
| Device Name: | Neodent Implant System – GM Line |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | JJGC Industria E Comercio De Materiais Dentarios S.A. Av. Juscelino Kubitschek De Oliveira, 3291 - CIC Curitiba, BR 81270-200 |
| Contact | Julianne De Oliveira Capucho Lechechem |
| 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 | 2017-12-22 |
| Decision Date | 2018-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878030560 | K173902 | 000 |
| 07899878028253 | K173902 | 000 |
| 07899878028277 | K173902 | 000 |
| 07899878027737 | K173902 | 000 |
| 07899878027744 | K173902 | 000 |
| 07899878027751 | K173902 | 000 |
| 07899878030454 | K173902 | 000 |
| 07899878030461 | K173902 | 000 |
| 07899878030478 | K173902 | 000 |
| 07899878030485 | K173902 | 000 |
| 07899878030492 | K173902 | 000 |
| 07899878030508 | K173902 | 000 |
| 07899878030515 | K173902 | 000 |
| 07899878030522 | K173902 | 000 |
| 07899878030539 | K173902 | 000 |
| 07899878030546 | K173902 | 000 |
| 07899878030553 | K173902 | 000 |
| 07899878028239 | K173902 | 000 |