The following data is part of a premarket notification filed by Odontit Sa with the FDA for Jjg Evolution Orthodontic Implant System.
| Device ID | K072917 |
| 510k Number | K072917 |
| Device Name: | JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ODONTIT SA MARCELO T DE ALVEAR 2099 3 DEG A-C1122AAE Buenos Aires, AR |
| Contact | Mario Gersberg |
| Correspondent | Mario Gersberg ODONTIT SA MARCELO T DE ALVEAR 2099 3 DEG A-C1122AAE Buenos Aires, AR |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-12 |
| Decision Date | 2008-01-14 |
| Summary: | summary |