The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios S.a. with the FDA for Zygomatic Implants.
| Device ID | K190718 |
| 510k Number | K190718 |
| Device Name: | Zygomatic Implants |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-20 |
| Decision Date | 2019-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878032052 | K190718 | 000 |
| 07899878031864 | K190718 | 000 |
| 07899878031888 | K190718 | 000 |
| 07899878031970 | K190718 | 000 |
| 07899878031987 | K190718 | 000 |
| 07899878031994 | K190718 | 000 |
| 07899878032007 | K190718 | 000 |
| 07899878032014 | K190718 | 000 |
| 07899878032021 | K190718 | 000 |
| 07899878032038 | K190718 | 000 |
| 07899878032045 | K190718 | 000 |
| 07899878031857 | K190718 | 000 |