The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Lythos Digital Impression System.
| Device ID | K141611 |
| 510k Number | K141611 |
| Device Name: | LYTHOS DIGITAL IMPRESSION SYSTEM |
| Classification | System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations |
| Applicant | ORMCO CORP. 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Courtney Clark |
| Correspondent | Courtney Clark ORMCO CORP. 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | NOF |
| CFR Regulation Number | 872.3661 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-16 |
| Decision Date | 2014-12-05 |
| Summary: | summary |