The following data is part of a premarket notification filed by Zuga Medical, Inc. with the FDA for Zuga Dental Implant System.
| Device ID | K171197 |
| 510k Number | K171197 |
| Device Name: | Zuga Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Zuga Medical, Inc. 24400 Chagrin Blvd, Suite 250 Beachwood, OH 44122 |
| Contact | Chan Wang |
| Correspondent | Chan Wang Zuga Medical, Inc. 24400 Chagrin Blvd, Suite 250 Beachwood, OH 44122 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-24 |
| Decision Date | 2018-06-30 |
| Summary: | summary |