The following data is part of a premarket notification filed by Spiraltech Superior Dental Implants, Inc. with the FDA for Spiraltech Dental Implant System.
Device ID | K170372 |
510k Number | K170372 |
Device Name: | SpiralTech Dental Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | SpiralTech Superior Dental Implants, Inc. 875 N Michigan Avenue, Suite 3106 Chicago, IL 60611 |
Contact | Daniel Rosenthal |
Correspondent | Angela Blackwell Blackwell Device Consulting Statesville, NC 28687 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-07 |
Decision Date | 2017-06-30 |
Summary: | summary |