The following data is part of a premarket notification filed by Insight Dental System with the FDA for Insight Dental System.
| Device ID | K170211 |
| 510k Number | K170211 |
| Device Name: | Insight Dental System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Insight Dental System 4766 Research Drive San Antonio, TX 78240 |
| Contact | Matthew Kaupp |
| Correspondent | David Furr FDC Services 8708 Capehart Cove Austin, TX 78733 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-24 |
| Decision Date | 2017-04-27 |
| Summary: | summary |