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 - Temporary Abutments.
| Device ID | K191191 |
| 510k Number | K191191 |
| Device Name: | Neodent Implant System - Temporary Abutments |
| 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 | Mariana Soares Hartmann |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road 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 | 2019-05-03 |
| Decision Date | 2019-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878033257 | K191191 | 000 |
| 07899878033110 | K191191 | 000 |
| 07899878033127 | K191191 | 000 |
| 07899878033134 | K191191 | 000 |
| 07899878033141 | K191191 | 000 |
| 07899878033158 | K191191 | 000 |
| 07899878033165 | K191191 | 000 |
| 07899878033172 | K191191 | 000 |
| 07899878033189 | K191191 | 000 |
| 07899878033196 | K191191 | 000 |
| 07899878033202 | K191191 | 000 |
| 07899878033219 | K191191 | 000 |
| 07899878033226 | K191191 | 000 |
| 07899878033233 | K191191 | 000 |
| 07899878033240 | K191191 | 000 |
| 07899878033103 | K191191 | 000 |