The following data is part of a premarket notification filed by Cadent, Ltd. An Align Technology Company with the FDA for Itero Software.
| Device ID | K131101 |
| 510k Number | K131101 |
| Device Name: | ITERO SOFTWARE |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY 2560 ORCHARD PKWY San Jose, CA 95131 |
| Contact | Manas M Lele |
| Correspondent | Manas M Lele CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY 2560 ORCHARD PKWY San Jose, CA 95131 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-19 |
| Decision Date | 2013-08-26 |
| Summary: | summary |