The following data is part of a premarket notification filed by Msi France with the FDA for Spi Dental Implant System.
Device ID | K172240 |
510k Number | K172240 |
Device Name: | SPI Dental Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | MSI France 5 Rue Des Halles Paris, FR 75001 |
Contact | Gerard Bouna |
Correspondent | Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030 -0172 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-26 |
Decision Date | 2018-01-31 |
Summary: | summary |